Contains Nonbinding Recommendations
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Photobiomodulation (PBM) Devices - 
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Premarket Notification [510(k)] 
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Submissions
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4 ______________________________________________________________________________
Draft Guidance for Industry and 
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Food and Drug Administration Staff
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DRAFT GUIDANCE
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This draft guidance document is being distributed for comment purposes only.
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Document issued on January 12, 2023.
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14  You should submit comments and suggestions regarding this draft document within 60 days of 
15  publication in the Federal Register of the notice announcing the availability of the draft 
16  guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments 
17  to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 
18  1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number listed in 
19 the notice of availability that publishes in the Federal Register.
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21  For questions about this document, contact OHT4: Surgical & Infection Control Devices / 
22 DHT4A: General Surgery Devices at (301) 796-6970.
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24
25
26 U.S. Department of Health and Human Services
27 Food and Drug Administration
28 Center for Devices and Radiological Health
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Preface
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34
Additional Copies
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36
37  Additional copies are available from the Internet. You may also send an e-mail request to CDRH-
38  Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 16030 
39 and complete title of the guidance in the request.
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Table of Contents
44
45
46 I.  Introduction ........................................................................................................................................................... 5 
47 II.  Background ............................................................................................................................................................ 6
48 III.  Scope ..................................................................................................................................................................... 6
49 IV.  Premarket Submission Recommendations ............................................................................................................. 7
50 A.  Device Description ........................................................................................................................................... 7
51 (1)  Anatomic Areas of Use ................................................................................................................................ 8
52 (2)  Light Generation .......................................................................................................................................... 8
53 (3)  Wavelength .................................................................................................................................................. 8
54 (4)  Energy Fluence (Radiant Dose) ................................................................................................................... 8
55 (5)  Spot Size ...................................................................................................................................................... 8
56 (6)  Output mode ................................................................................................................................................. 8
57 (7)  Radiant Power and Irradiance ...................................................................................................................... 8
58 (8)  Pulsing Parameters (if applicable) ................................................................................................................ 9
59 B.  Predicate Comparison ....................................................................................................................................... 9
60 C.  Labeling ............................................................................................................................................................ 9
61 (1)  Indications for Use ..................................................................................................................................... 10
62 (2)  Warnings .................................................................................................................................................... 10
63 (3)  Precautions ................................................................................................................................................. 11
64 (4)  Overview of Clinical Studies ..................................................................................................................... 11
65 D.  Reprocessing .................................................................................................................................................. 11
66 E.  Biocompatibility ............................................................................................................................................. 11
67 F.  Software.......................................................................................................................................................... 12
68 G.  Usability Study Considerations for Over the Counter (OTC) Home Use PBM Devices................................ 14
69 H.  Electrical Safety and Electromagnetic Compatibility (EMC) ......................................................................... 15
70 I.  Wireless Technology ...................................................................................................................................... 16
71 J.  Thermal Safety ............................................................................................................................................... 16
72 K.  Eye Safety ....................................................................................................................................................... 17
73 L.  Clinical Performance Testing ......................................................................................................................... 17
74 (1)  Purpose/Objective ...................................................................................................................................... 18
75 (2)  Controls ...................................................................................................................................................... 19
76 (3)  Inclusion/Exclusion Criteria ....................................................................................................................... 19
77 (4)  Radiant Dose Selection .............................................................................................................................. 21
78 (5)  Study Endpoints ......................................................................................................................................... 21
79 (6)  Study Duration and Follow-Up Schedule .................................................................................................. 22
80 (7)  Statistical Considerations ........................................................................................................................... 22
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81 (8)  Adverse Event Monitoring ......................................................................................................................... 23
82 M.  Modifications .................................................................................................................................................. 23
83 Appendix A. Glossary of Terms .................................................................................................................................. 25
84 Appendix B. Labeling Examples ................................................................................................................................. 26
85 Warnings....................................................................................................................................................26
86 Precautions.................................................................................................................................................26
87
88
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Photobiomodulation (PBM) Devices - 
89
Premarket Notification [510(k)] 
90
Submissions
91
92
Draft Guidance for Industry and 
93
Food and Drug Administration Staff 
94
95
96 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
97 Administration (FDA or Agency)on this topic. It does not establish any rights for any person 
98 and is not binding on FDA or the public. You can use an alternative approach if it satisfies the 
99 requirements of the applicable statutes and regulations. To discuss an alternative approach, 
100 contact the FDA staff or Officeresponsible for this guidance as listed on the title page.
101
I. Introduction
102
103 This draft guidance document provides draft recommendations for 510(k) submissions for 
104 photobiomodulation (PBM) devices, also known as low level light therapy (LLLT) devices, 
105 which are intended for use in applications such as aesthetics, dermatology, and other general 
106 indications. The device is designed to deliver a non-heating dose of light energy into the body to 
107 provide clinical benefit to the patient. The recommendations reflect current review practices and 
108 are intended to promote consistency and facilitate efficient review of these submissions.
109
110 For the current edition of the FDA-recognized consensus standard(s) referenced in this 
111 document, see the FDA Recognized Consensus Standards Database at
112 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.For more 
113 information regarding use of consensus standards in regulatory submissions, refer to FDA 
114 guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
115  for Medical Devices.1  
116   
117  In general, FDA guidance documents, including this guidance, do not establish legally 
118  enforceable responsibilities. Instead, guidances describe the Agencys current thinking on a topic 
119  and should be viewed only as recommendations, unless specific regulatory or statutory 
120  requirements are cited. The use of the word should in Agency guidance means that something is 
121 suggested or recommended, but not required.
1 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-
standards-premarket-submissions-medical-devices. 
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II.  Background
122
123 For the purpose of this guidance, the term photobiomodulation is defined as the application of 
124 light at an irradiance that does not induce heating with the goal of altering biological activity.2
125 The PBM device may use a light source that is coherent (laser) or non-coherent (filtered 
126 broadband lamps or light-emitting diodes (LED)), or a combination of both. PBM is commonly 
127 provided by using light in the visible and near infrared spectral ranges, but PBM effects are not 
128 exclusive to these ranges. PBM therapy is provided at a much lower fluence and irradiance 
129 compared to ablative or coagulating light devices such as those using high power lasers or 
130 intense pulsed light (IPL) sources. The mechanism of actions for PBM for different clinical 
131 indications is not fully understood. Outcomes are dependent on many factors such as wavelength 
132 of light, fluence, irradiance, pulsing parameters, and beam spot size.
133
134 This guidance supplements other FDA guidance documents regarding the specific content 
135 requirements and recommendations of a premarket notification (510(k)) submission. You should 
136 also refer to 21 CFR 807.87 and FDAs guidance, Format for Traditional and Abbreviated 
137  510(k)s.3 
138   
III.  Scope 
139 
140 The scope of this document is limited to the class II PBM medical devices4 regulated under 21 
141 CFR 878.4810, 878.4860, 878.5400, and890.5500 and with product codes listed in the table 
142 below:
143
144 Table 1. Product codes within the scope of this guidance.
145
Product Code Regulation Number Product Code Name
GEX5 878.4810 Powered laser surgical instrument
OLP 878.4810 Over-the-counter,powered,light based laser for 
acne
OHS 878.4810 Light based over the counter wrinkle reduction
OKJ 878.48606 Light based treatment for cold sores herpes 
simplex virus-1
2 Semin Cutan Med Surg. 2013 March; 32(1): 4152.
3 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-
510ks-guidance-industry-and-fda-staff.
4 Note that, as used in this guidance, class II refers to the medical device classification and not the laser 
classification as defined in 21 CFR 1040.20. Any class laser (I thru IV) can be classified as a class I, II, or III 
medical device depending on the intended use and technology for the specific device.
5 Not exclusive to PBM devices. Devices that are not PBM devices under this product code are outside the scope of 
this guidance document.
6 Devices in this classification are subject to special controls. See 21 CFR 878.4860(b).
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OLI 878.54007 Fat reducing low level laser
OAP 890.5500 Laser, comb, hair
NHN 890.5500 Powered, light based, laser, non-thermal 
instrument with non-heating effect for adjunctive 
use in pain therapy
146
147 The scope of this guidance also pertains to the PBM component of devices that combine a PBM 
148 device listed in the table above with another device(s) (e.g., electrostimulation source, 
149 mechanical massager, or ultrasound) in a single system operating simultaneously or sequentially 
150 to achieve a desired clinical effect. 
151
152 Light-emitting products that are intended for only general wellness use and present a low risk to 
153 the safety of users and other persons, are not within the scope of this guidance. For details on 
154  whether or not your device is a general wellness product, refer to the guidance General 
155  Wellness: Policy for Low Risk Devices.8 
156   
157 Some of the recommendations in this guidance may assist in complying with some of the special 
158 controls for light based treatment devices for cold sores herpes simplex virus-1 and fat reducing 
159 low level lasers. For information regarding special controls for light based treatment devices for 
160 cold sores herpes simplex virus-1,see 21 CFR 878.4860(b). For information regarding special 
161 controls for fat reducing low level lasers, see 21 CFR 878.5400(b) and Class II Special Controls 
162  Guidance Document: Low Level Laser System for Aesthetic Use. 
163   
164  For specific questions or feedback on your proposed clinical or bench testing to show substantial 
165  equivalence of your device, we recommend that you contact the Agency through the Q-
166  submission process to obtain further guidance. For details on the Q-Submission Program, please 
167  refer to the guidance Requests for Feedback and Meetings for Medical Device Submissions: 
168  The Q-Submission Program.9 
169   
IV.  Premarket Submission Recommendations 
170 
A.  Device Description 
171 
172  We recommend you identify your device by the applicable regulation number and product code 
173  indicated in Section III above and include the information described below for devices 
174  incorporating a PBM light source with specific attention to the recommendations applicable to 
175 the indications for use (IFU) for your device.  The technical parameters of the device 
7 This classification regulation is subject to special controls. See 21 CFR 878.5400(b) and Class II Special Controls 
Guidance Document: Low Level Laser System for Aesthetic Use available at https://www.fda.gov/medical-
devices/guidance-documents-medical-devices-and-radiation-emitting-products/low-level-laser-system-aesthetic-use-
class-ii-special-controls-guidance-industry-and-fda-staff. 
8 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-
devices. 
9 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
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176  characteristics described in recommendations 3-8 below should be measured by testing the final 
177  version of your device. The measurement or derivation methods that were used should be 
178  provided as a part of the bench testing information. Note that the technical parameters of cold 
179  sore devices, including wavelength, treatment time, treatment area, energy density, spot size, and 
180 power, must be characterized (21 CFR 878.4860(b)(1)).
(1) Anatomic Areas of Use 
181
182  We recommend you provide a detailed description of the anatomic areas of use of the device, 
183 including the following information:
184   The size and the shape of the anatomical site that will be illuminated by treatment light 
185  during the treatment procedure, the distance of the light source from the site during 
186 treatment, and the means by which this distance will be maintained during treatment. 
187   The number of treatments per session, number of sessions per week, and the total number 
188 of sessions.
189   Instructions for treatment area preparation, pre- and post- procedure evaluation, and post-
190 procedure care.
(2) Light Generation 
191
192  We recommend you describe the details of the light or laser generation method. This description 
193  may include the laser gain medium, pumping source, and the technology used for pulsing, as 
194  applicable. If the light is generated without a gain medium (e.g., by broadband lamps or LEDs), 
195 we recommend providing detailed specifications and engineering drawings of the light source(s). 
(3) Wavelength 
196
197  We recommend you identify the individual wavelength or the range of wavelengths of light in 
198 nanometers (nm) that will be delivered to the patients body by the device. 
(4) Energy Fluence (Radiant Dose) 
199
200  We recommend you identify the total energy (in J or mJ) and total fluence (or radiant dose 
201  defined as energy per area, usually in J/m2 or mJ/cm2), delivered at each spot on the tissue 
202  surface. If the clinical treatment procedure includes multiple steps, the submission should 
203 identify the energy delivered to a spot at each step as well as the total energy delivered to a spot. 
(5) Spot Size 
204
205 We recommend you describe the spot size(s) (in mm) that will be used for the procedure. 
(6) Output mode 
206
207  We recommend you indicate whether the light output mode is pulsed or continuous wave (CW) 
208 or another novel output mode. 
(7) Radiant Power and Irradiance 
209
210  We recommend you identify the radiant power (W) and irradiance (radiant power per area, 
211 usually in W/m2 or mW/cm2) that will be delivered to the tissue during the procedure. 
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(8) Pulsing Parameters (if applicable) 
212
213 We recommend you describe the following parameters for pulsed lasers and light sources: 
214
215   Pulse duration (in milliseconds): The length of time during which the instantaneous laser 
216 power is at least half the peak power;
217  Pulse shape: Square, Gaussian, Trapezoid, etc.; 
218  Energy per pulse (mJ): Energy delivered during a single pulse;
219  Fluence per pulse (mJ/cm2): Energy delivered per area per pulse during a single pulse; 
220  Duty cycle (%): The percentage of time the laser is on;
221  Repetition rate (Hz): Number of pulses delivered at each second; 
222  Laser beam profile: Circle, Line, Square, Gaussian, etc.; and
223  Average Power: Energy delivered per each second. 
224
B.  Predicate Comparison
225
226  For devices reviewed under the 510(k) process, manufacturers must compare their new device to 
227  a similar legally marketed predicate device to support its substantial equivalence (section 513(i) 
228  of the Federal Food, Drug, and Cosmetic Act (FD&C Act); 21 CFR 807.87(f)). This comparison 
229  should provide information to show how your device is similar to and different from the 
230  predicate. Side by side comparisons, whenever possible, are desirable. See below for an example 
231  of how this information could be organized. This table is not intended to represent an exhaustive 
232  list of comparative parameters; ensure you provide all relevant device descriptive characteristics 
233 as outlined in the Device Description section, above.
234
235  Table 2. Sample predicate comparison table to outline differences and similarities between 
236 the subject and predicate devices.
Description Subject Device Predicate Device 
(Kxxxxxx)
Indications for Use
Output wavelength(s)
Energy fluence
Irradiance
Treatment regimen
Spot size
...
237
C.  Labeling 
238
239  The premarket notification must include proposed labeling in sufficient detail to satisfy the 
240  requirements of 21 CFR 807.87(e). Proposed labels and labeling, sufficient to describe the PBM 
241 device, its intended use, and the directions for use must be provided.
242
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243 PBM devices that are prescription devices are exempt from having adequate directions for lay 
244 use under section 502(f)(1) of the FD&C Act as long as the conditions in 21 CFR 801.109 are 
245 met. For instance, labeling must include adequate information for practitioner use of the device, 
246 including indications, effects, routes, methods, frequency and duration of administration and any 
247 relevant hazards, contraindications, side effects and precautions. (21 CFR 801.109(d).) 
248
249  PBM devices that are over the counterdevices must include adequate directions for use(21 CFR 
250 801.5). The labeling (e.g., package insert) must describe the intended use of the device and
251 include a listing of indications (21 CFR 801.5(a)). The labeling recommendations below are not 
252 intended to capture all possible limitations or instructions for all PBM devices. Therefore, when 
253 developing your labeling, it may be necessary for you to include additional limitations (e.g., 
254 contraindications, warnings, precautions, adverse reactions), and other instructions that are 
255 appropriate for your device, depending on its specific design, features, and performance 
256 characteristics, and depending on the results and conclusions drawn from a usability study (see 
257 Section G).
258 Note that the labeling for cold sore devices must direct end-users to contact the device 
259 manufacturer and MedWatch if they experience any adverse events when using thedevice(21 
260 CFR 878.4860(b)(5)).Labeling for cold sore devices also must include specific information 
261 pertinent to use of the device by the intended patient population and the treatment regimen (21 
262 CFR 878.4860(b)(6)).See Class II Special Controls Guidance Document: Low Level Laser 
263 System for Aesthetic Use10 forlabeling special controls for fat reducing low level lasers (21 
264 CFR 878.5400).
265 In addition to the labeling requirements in 21 CFR part 801 and 21 CFR 1010.2 and 1010.3, the 
266 user manual/operator manual/package insert/box labeling should include the following 
267 information: 
(1)Indications for Use
268
269  You should provide a clear statement of your devices Indications for Use. If your device 
270  consists of multiple components with different indications, we recommend that you specify this 
271  in your labeling. If your device is intended for use with another device, we recommend that you 
272 identify that device in your labeling.
(2) Warnings
273
274  We recommend you prominently display (e.g., using emphasized text) appropriate warnings in 
275  the instructions for use regarding how to avoid known hazards associated with the use of your 
276 PBM devices. We believe such warnings should include the following information: 
277
278  A statement regarding the long term effects of prolonged use of the device.
279  A statement that warns against the use of non-thermal lasers during pregnancy.
280  A statement that warns against using non-thermal lasers over or near cancerous lesions.
10 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/low-
level-laser-system-aesthetic-use-class-ii-special-controls-guidance-industry-and-fda-staff.
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281  A statement that warns of the risks of injury resulting from misuse of device. 
282
283  Specific examples of warnings that follow these recommendations are provided in Appendix B. 
(3) Precautions 
284 
285 We recommend you prominently display appropriate precautions (e.g., using emphasized text) 
286 for the safe and effective use of the devicein the instructions for use. We believe such 
287 precautions should include the following information:
288
289  A statement regarding the use of safety glasses by patient during treatment.
290  A statement that caution should be exercised when using the deviceover skin area that 
291 lacks normal sensation.
292  A statement that the device should be used with only manufacturer recommended 
293 accessories.
294  A statement that the ingress of any liquid should be avoided. 
295
296 Specificexamples of precautions that follow these recommendations are provided in Appendix 
297 B.
(4)Overview of Clinical Studies
298
299 If applicable, we recommend including in your instructions for use an overview of the results of 
300 clinical studies conducted with the device. 
301
D. Reprocessing
302
303 Significance: Many of the patient contacting components of PBM devices are reused and should 
304 be adequately cleanedand disinfected between uses to minimize infections while preventing
305 device degradation. 
306
307 Recommendation: You should provide instructions on how to reprocess a reusable device that is 
308 provided non-sterile to the user. Such instructions are important to ensure that thedevice is 
309 appropriately prepared for its initial and subsequent uses. For recommendations regarding the 
310 development and validation of reprocessing instructions in your proposed device labeling, refer 
311 to FDAs guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods 
312 and Labeling.11
313
314 Note that for cold sore devices, the cleaning and disinfection instructions for the device must be 
315 validated (21 CFR 878.4860(b)(2)).
E. Biocompatibility
316
317 Significance: PBM devices contain patient-contacting materials, which, when used as intended, 
318 (i.e., contact type and duration), may induce a harmful biological response.  
11 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-
health-care-settings-validation-methods-and-labeling. 
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319
320 Recommendation: You should determine the biocompatibility of all patient-contacting materials 
321 present in your device. If your device is identical in composition and processing methods to a 
322 PBM devicewith a history of successful use, you may reference previous testing experience or 
323 the literature, if appropriate. For some device materials, it may be appropriate to providea 
324 reference to either a recognized consensus standard, or to a Letter of Authorization (LOA) for a 
325 device Master File (MAF).You should refer to the following FDA webpage for additional 
326 information on using device MAFs: https://www.fda.gov/medical-devices/premarket-approval-
327 pma/master-files.
328
329 If you are unable to identify a legally marketed predicate device with similar location/duration of 
330 contact and intended use that uses the same materials as used in your device, we recommend you 
331 conduct and provide a biocompatibility risk assessment. The assessment should explain the 
332 relationship between the identified biocompatibility risks, the information available to mitigate 
333 the identified risks, and identify any knowledge gaps that remain. You should then identify any 
334 biocompatibility testing or other evaluations that were conducted to mitigate any remaining risks.
335
336 We recommend that you follow FDAs guidance Use of International Standard ISO 10993-1, 
337 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk 
338  management process12, which identifies the types of biocompatibility assessments that should 
339 be considered and recommendations regarding how to conduct related tests. 
340
341 As described in ISO 10993-1: Biological evaluation of medical devices  Part 1: Evaluation and 
342 testing within a risk management process and Attachment A of FDAs guidance on ISO-10993-
343 1,PBM devices aretypically considered surface devices in contact with intact skin for a limited 
344 contact duration (less than 24 hours). Therefore,we recommendthe following endpoints be 
345 addressed in your biocompatibility evaluation:
346
347   cytotoxicity;
348   sensitization; and
349   irritation or intracutaneous reactivity.
350 
351  Note that cold sore devices must be demonstrated to be biocompatible (21 CFR 878.4860(b)(3)). 
352  See Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic 
353 Use13 for special controls related to biocompatibility for fat reducing low level lasers (21 CFR 
354 878.5400).
F. Software
355
356 Significance: Software in PBM devices ensures that appropriate energy is delivered to the patient 
357 within an appropriate timeframe.Adequate software performance testing provides assurance that 
358 the device is operating within safe parameters.
12 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and. 
13 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/low-
level-laser-system-aesthetic-use-class-ii-special-controls-guidance-industry-and-fda-staff.
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359
360 Recommendation: Refer to the FDA software guidance Guidance for the Content of Premarket 
361 Submissions for Software Contained in Medical Devices14 for a discussion of the software 
362 documentation that you should provide in your submission. The software guidance outlines the 
363 type of documentation to be provided based on the level of concern associated with the device.
364  FDA generally considers the software for PBM devices to present a minor or moderate level 
365  of concern. PBM devices with software functions limited to an on/off switch and/or timer 
366 function may fall under a minor level of concern, in comparison to a moderate level of 
367 concern for devices whose software controls treatment parameters.15 However, new indications, 
368 applications, or technological characteristics may result in a higher level of concern. If you 
369 believe that the software in your device presents either a minor or a moderate level of 
370 concern as defined in the software guidance, we recommend you provide a scientific justification 
371 that supports your rationale forthe level of concern based on the possible consequences of 
372 software failure.
373
374 We recommend that you provide a full description of the software/firmware supporting the 
375 operation of the subject device following the software guidance, commensurate with the 
376 appropriate level of concern. This recommendation applies to original device/systems as well as 
377 to any software/firmware changes made to already-marketed devices.Changes to software must 
378 be re-validated and re-verified in accordance with Design Controls, 21 CFR 820.30(g)(i), and 
379 documented in the Design History File, 21 CFR 820.30(j).Some software changes may warrant 
380 the submission of a new 510(k). For further information on this topic, refer to Deciding When 
381 to Submit a 510(k) for a Software Change to an Existing Device.16
382
383 As appropriate, we also recommend you provide information on the cybersecurity aspects of 
384 your device. For more information on this topic, see FDAs guidance Content of Premarket 
385 Submissions for Management of Cybersecurity in Medical Devices.17
386
387 If yourdevice includes off-the-shelf software, we recommend you provide the additional 
388 information discussed in the FDAguidancedocuments titled Off-the-Shelf Software Use in 
389 Medical Devices18 andCybersecurity for Networked Medical Devices Containing Off-The-
390 Shelf (OTS) Software,19 which provide additional information regarding medical devices 
391 utilizing off-the-shelf software. 
14 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-
submissions-software-contained-medical-devices. 
15 Note that the Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use 
indicates that FDA believes that the software used to operate a low level laser for aesthetic use (21 CFR 878.5400) 
presents a moderate level of concern because a failure or latent design flaw could directly result in minor injury to 
the patient or operator.
16 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-
software-change-existing-device. 
17 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-
management-cybersecurity-medical-devices-0. 
18 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices. 
19 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-networked-medical-
devices-containing-shelf-ots-software. 
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392
393  Overall, we recommend that the documentation related to the software contained in your device 
394  provide sufficient evidence to describe the role of the software included in the device, and 
395 performance testing to demonstrate that the software functions as designed.
396
G.  Usability Study Considerations for Over the Counter 
397 
(OTC) Home Use PBM Devices 
398
399  To support a marketing submission for an OTC PBM device, we recommend that you perform 
400  three usability studies to 1) demonstrate that lay users can correctly self-select themselves as 
401  being appropriate users of the device for the stated indication by reading the box labeling, 2) 
402  demonstrate that lay users can correctly and safely use the device after reading and following the 
403  instructions for use, and 3) assess the understanding and comprehension by lay users of 
404  the patient labeling including all indications, contraindications, warnings and precautions. Note 
405  that for cold sore devices, simulated use testing must include information from a usability, label 
406  comprehension and self-selection study to demonstrate that the device can be used by the 
407 intended patient population without any assistance (21 CFR 878.4860(b)(7)).
408
409 We recommend that the following points be considered when conducting these studies:
410
411   The studies can be conducted individually or can be combined. One or more of the 
412  usability studies can also be combined with a clinical study designed to assess safety and 
413 effectiveness of the device.
414
415   The subjects enrolled for the usability studies should be representative of the intended use 
416 population. 
417
418   We recommend you initially test the patient labeling in a group of a few subjects. If 
419  needed, the labeling should be revised based on the outcome of a small study. This 
420  process should be repeated using small studies until there is no need for significant 
421  modifications to the labeling. Then, the final draft of the labeling should be tested in a 
422 larger study. 
423
424   Whenever the patient labeling is modified, the final version should be tested to 
425  demonstrate the revised labeling is effective in providing instructions to the intended 
426 patient population for the specific intended use.
427
428   When applicable, changes made on one part of the labeling should be incorporated to the 
429  rest of the labeling. For example, changes to the box label should be incorporated in the 
430 instructions for use and vice-versa.
431
432   We recommend you include important safety instructions and warnings (e.g., eye safety) 
433  on the box labeling to inform the self-selection and in case a layperson does not choose to 
434 read the instructions for use. 
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435
436 A study protocol canbe submitted to FDA in aPre-Submission to obtain FDAs feedback prior 
437 to conducting the study. For more information on the Q-submission program, refer to the 
438 following guidance document: Requests for Feedback and Meetings for Medical Device 
439  Submissions: The Q-Submission Program.20 
440   
441 Alternatively, you can provide a justification for why only a part or none of the three
442 recommendedusability studies should be provided to support a marketing submission for a PBM 
443 device intended to be marketed OTC. For cold sore devices, if a different approach was used to 
444 satisfy thespecial control for simulated use testing (21 CFR 878.4860(b)(7)), this information
445 must be provided in your submission.
446
447 Devices used in the home or other non-clinical environments are associated with unique risks 
448 created by the interactions among the user (often a layperson), the use environment, and the 
449  device. Refer to the following guidance for factors that should be considered during home use 
450  device design and development: Design Considerations for Devices Intended for Home Use21 
451  Additional recommendations on patient labeling can be found in the FDA guidance Guidance 
452  on Medical Device Patient Labeling22 
453   
H.  Electrical Safety and Electromagnetic Compatibility 
454 
(EMC) 
455 
456  Significance: PBM devices are medical electrical equipment and therefore may expose the 
457  operator and patient to hazards associated with the use of electrical energy or may fail to operate 
458  properly in the presence of electromagnetic disturbance. 
459  
460 Recommendation: PBM devices should be tested to demonstrate that they perform as anticipated 
461 in their intended use environment. We recommend that this testing be performed as described in 
462 the currently FDA recognized versions of the following standards for medical electrical 
463 equipment safety and electromagnetic compatibility:
464
465   ANSI/AAMI ES60601-1: Medical electrical equipment - Part 1: General requirements 
466 for basic safety and essential performance
467
468   ANSI/AAMI IEC 60601-1-2: Medical electrical equipment - Part 1-2: General 
469  requirements for basic safety and essential performance - Collateral standard: 
470 Electromagnetic compatibility - Requirements and tests
471
20https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program. 
21 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-devices-
intended-home-use. 
22 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-
labeling. 
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472 Note that for cold sore devices, performance testing must validate electromagnetic compatibility 
473 (EMC) and electrical safety of the device (21 CFR 878.4860(b)(4)).See Class II Special 
474 Controls Guidance Document: Low Level Laser System for Aesthetic Use23 for special controls 
475 related to electrical safety and electromagnetic compatibility for fat reducing low level lasers (21 
476 CFR 878.5400). If submitting adeclaration of conformity to the above standards, we recommend 
477 that appropriate supplemental information be provided, such as an assessment of the results and 
478 how conformity was determined, and information regarding test methods used.This is because 
479 the aboveseries of standards includes general methods with multiple options and, in some cases, 
480 does not include specific acceptance criteria or address assessment of results. For additional 
481 information on providing electromagnetic compatibility information in a premarket submission, 
482 see FDAs guidance, Information to Support a Claim of Electromagnetic Compatibility (EMC) 
483  of Electrically-Powered Medical Devices.24 
484   
I.  Wireless Technology
485
486  Significance: In the design, testing, and use of wireless medical devices, the correct, timely, and 
487  secure transmission of medical data and information is essential for the safe and effective use of 
488  both wired and wireless medical devices and systems.  
489   
490  Recommendation: If your PBM device incorporates radiofrequency wireless technology such as 
491  Bluetooth, IEEE 802.11 (Wi-FiTM), or radio frequency identification (RFID) technology, we 
492  recommend testing beyond what is specified in the IEC 60601 standards to demonstrate that the 
493  wireless device functions will perform as intended in environments with other wireless products. 
494 For additional recommendations for home use devices with wireless technology, please refer to 
495 FDAs guidance Design Considerations for Devices Intended for Home Use.25
496
497 We recommend that you consult FDAs guidance, Radio Frequency Wireless Technology in 
498 Medical Devices26 for additional recommendations on this topic.
499
J. Thermal Safety
500
501 Significance: PBM devices are not intended to raise skin or body temperature as the mechanism 
502 of action. However, it is possible for some PBM devices with relatively higher irradiancesor 
503 devices that cover certain partsof the body (e.g., masks and helmets) to increase the tissue 
504 temperature to dangerous levels if used for long periods of time and/or in close contact. 
505
23 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/low-
level-laser-system-aesthetic-use-class-ii-special-controls-guidance-industry-and-fda-staff.
24 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-support-claim-
electromagnetic-compatibility-emc-electrically-powered-medical-devices. 
25 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-devices-
intended-home-use. 
26 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radio-frequency-wireless-
technology-medical-devices-guidance-industry-and-fda-staff. 
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506 Recommendation: For PBM devices that can unintentionally increase the tissue temperature, the 
507 risk of burning thepatient should be mitigated. We recommend that youdemonstrate that no 
508 tissuedamage will be caused by your device, using appropriate technological comparisons or 
509 performance testing data, such as skin temperature measurements. If your device is likely to 
510 induce tissue damage due to inadvertent overuse, we recommend placing built-in time limits in 
511 the software or firmware of your device,especially for an over-the-counter device. We also 
512 recommend using tissue temperature sensors to detect any potential harmful temperature rise and 
513 shut off device output, when needed.
514
K. Eye Safety
515
516 Significance: PBM devices pose a risk for ocular tissue damageas they may deliver energy and 
517 irradiance values greater than the maximum permissible exposure for the patients or users eyes.
518
519 Recommendation: When a PBM device has the potential to harm the eyes of an operator or a 
520 treated individual, safety measures,such as the use of safety eyewear and/or skin contact sensors,
521 should be included in the instructions for use to mitigate the risk. We recommend that you 
522 measure the energy and irradiance output values of your device to determine which safety 
523 measures, if any, would be appropriate. Note that cold sore devices performance testing must 
524 validate ocularsafety of the device (21 CFR 878.4860(b)(4)).
525
L. Clinical Performance Testing
526
527 Significance: In somecases, non-clinical evaluation does not fully characterize all clinical 
528 experience, outcomes, and risks. In such cases, we recommend that you conduct in vivo (i.e., 
529 clinical) studies to evaluate device safety and effectiveness for new and modifiedPBM devices.
530 Compared to the predicate device, changes in indications for use, output parameters, or treatment 
531 regimen may warrant clinical studies to assess the clinical benefit of thePBM device. 
532
533 Recommendation: We recommend you conduct in vivo (i.e., clinical) studies to determine the 
534 safety and effectiveness for new and modified PBM devices when the device is operated by the 
535 intended user, on the target population, and as instructed in the labeling. In order to provide this 
536 information, we recommend that clinical studies of the PBM devicebe designed to reflect the use 
537  in the intended populations as closely as possible. Note that for cold sore devices, clinical data 
538 must show adequate reduction in time to healing and assess risks of redness, discomfort, burns, 
539 and blisters (21 CFR 878.4860(b)(8)). See Class II Special Controls Guidance Document: Low 
540 Level Laser System for Aesthetic Use27 for special controls related to clinical testing of fat 
541 reducing low level lasers (21 CFR 878.5400).
542
543  If a clinical study is needed to demonstrate substantial equivalence, i.e., conducted prior to 
544  obtaining 510(k) clearance of the device, the study must be conducted under the Investigational 
545 Device Exemptions (IDE) regulation, 21 CFR Part 812. Generally, we believe PBM devices
27 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/low-
level-laser-system-aesthetic-use-class-ii-special-controls-guidance-industry-and-fda-staff.
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546 within the scope of this guidance are non-significant risk devices; therefore, the study would be 
547 subject to the abbreviated requirements of 21 CFR 812.2(b). However, if your PBM device is 
548 intended to treat a disease or condition in a way that would alter the standard of care (e.g.,
549 trauma treatment) then the device could be considered a significant risk device subject to all 
550 requirements of 21 CFR 812. See the FDA Guidance titled, Significant Risk and Nonsignificant 
551 Risk Medical Device Studies.28 In addition to the requirements of 21 CFR Part 812, sponsors of 
552 such trials of a device conducted in the United States must comply with the regulations 
553 governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50). 
554
555 When data from clinical investigations conducted outside the United States are submitted to 
556 FDA for these devices, the requirements of 21CFR 812.28 may apply.29 21 CFR 812.28 outlines 
557 the conditions for FDA acceptance of clinical data from investigations conducted outside the 
558 United States when submitted to support premarket submissions. For more information, see the 
559 FDA guidance Acceptance of Clinical Data to Support Medical Device Applications and 
560 Submissions: Frequently Asked Questions.30
561
562 In some cases, real-world data (RWD) can be used to support expansion of the indication for a 
563 device for which 510(k) clearance has already been obtainedas long as the intended use of the 
564 device remains the same. Whether the collection of RWD for a legally marketed device requires 
565 an IDE depends on the particular facts of the situation. Specifically, if a cleared deviceis being 
566 used in the normal course of medical practice, an IDE would likely not be required. For 
567 additional information regarding this topic, please refer to the FDA Guidance entitled Use of 
568  Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.31  
569   
570  FDA encourages you to seek early feedback on your proposed study design using the Q-
571  submission process. For information on the Q-submission process see FDAs guidance 
572  Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission 
573  Program.32 
(1) Purpose/Objective 
574 
575  We recommend that the study objectives be defined to support the performance of the device as 
576  described in the proposed indication for use. Performance assessments should generally address 
577  both the desired outcome(s) (i.e., effectiveness) and potential undesired effects, to support 
578  benefit-risk analysis. The outcomes of the study should be evaluated in the context of 
579 performance previously demonstrated for the predicate device(s); therefore, the objectives of the 
28 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/significant-risk-and-nonsignificant-
risk-medical-device-studies. 
29 This applies to data from clinical investigations that began on or after February 21, 2019, and are submitted to 
support a premarket submission, including IDEs, premarket approval (PMA) applications, and 510(k)s.
30 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-clinical-data-support-
medical-device-applications-and-submissions-frequently-asked.
31 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-
regulatory-decision-making-medical-devices. 
32 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program.
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580 study should be designed to facilitate comparative analysis. For example, a device for hair 
581 growth could be designed with an objective to determine the increase in number of terminal hairs 
582 percentimeter. To demonstratesubstantially equivalent performance, the mean increase in hair 
583 density of the subject devicewould then be comparedto the increased density when using the 
584 predicate device in its clinical studies. 
(2)Controls
585
586 For most indications treated with PBM devices, control arms will aid in distinguishing device-
587 induced effects from background effects,such as placebo or natural history of the condition.
588 Depending on the indications for use, appropriate strategies may include contralateral control, 
589 sham treatments, or other control designs that allow the investigator to compare the changes in 
590 areas exposed to PBM with the changes in a matched body area that was not exposed to PBM.
591 We recommend that treatment and control assignments be blinded from the study subjects and 
592 from the investigator(s) performing the post-treatment evaluations.
593
(3)Inclusion/Exclusion Criteria
594
595 We recommend that selection of study subjects include all subjects for whom a device is 
596 intended, with qualifying criteria for minimum or maximum severity of the condition to be 
597 treated, when appropriate.However, some subjects whose condition would warrant their 
598 inclusion in the study may not beappropriatecandidates due to safety concerns related to their 
599 health, age, skin type, co-existing or prior conditions or treatments, or other factors that might be 
600 negatively impacted by the test treatment or the control treatment.
601
602 When developing your clinical study, we recommend you consider the following parameters or 
603 characteristics in your inclusion and exclusion criteria, including but not limited to: 
604
605 Inclusion: 
606  Age: The age range should reflect that of the expected population for the proposed 
607  indication for use. Studies that involve pediatric or geriatric patients may warrant 
608  additional considerations to address potential for variable performance in these 
609  populations. For more information regarding the evaluation and reporting of age, race, 
610  ethnicity and sex-specific data in medical device clinical studies, see FDAs guidances 
611  Evaluation of Sex-Specific Data in Medical Device Clinical Studies33 and Evaluation 
612  and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical 
613  Studies.34 
614   
615    Sex and gender: For certain indications, sex or gender may impact the natural history of 
616  the condition being treated as well as the response to treatment. In such circumstance, 
617  studies could be designed to limit enrollment based on sex or gender. You should note 
618 that, in these cases, subsequent labeling should reflect the study population sex or gender.
33 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-sex-specific-data-
medical-device-clinical-studies-guidance-industry-and-food-and-drug.
34 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-and-reporting-age-race-
and-ethnicity-specific-data-medical-device-clinical-studies.
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619
620   Skin type: Different Fitzpatrick skin phototypes may have different treatment-emergent 
621  risks with energy-based treatment. In designing the study and the inclusion/exclusion 
622  criteria, we recommend you consider whether your device would be applied differently 
623  for individuals with darker or lighter Fitzpatrick skin phototypes. This consideration may 
624  affect whether you include a separate treatment protocol (e.g., different energy output) 
625  for a subgroup of subjects or whether the subgroup should be excluded from the study. 
626  Due to increased risk of adverse events in certain skin types, the labeling should reflect 
627 the skin types evaluated in the conducted clinical studies.
628
629    Body site: Certain Indications for Use statements may specify body sites. In such cases, 
630  performance testing on the specific body sites may be needed. For an indication for use 
631  for the whole body, data obtained from three or more discrete anatomic locations justified 
632  to be representative of the entire body may sufficiently represent the entire body of the 
633 patient.
634
635    Subtype and/or severity: For some disorders, you may choose to exclude very mild or 
636  very severe disease due to benefit-risk considerations, or to limit enrollment to subjects 
637  with specific subtypes of the disorder. When studies are performed in a subtype- or 
638  severity-restricted population, labeling should reflect the range of severity for which 
639 performance testing data is available.
640
641 Exclusion:
642  General health considerations for safe participation in a study.
643
644  Photosensitivity disorder to light in the spectrum delivered by the device.
645
646  Photosensitizing medication use.
647
648   Pregnant; planning pregnancy before the end of the study; of childbearing potential and 
649 not using birth control; or lactating. 
650
651   Active infection, wound, or skin lesion in the area to be treated (unless the indication 
652 being assessed is treatment of an active infection, wound, or skin lesion).
653
654  Skin cancer or history of skin cancer at the treatment site.
655
656   Active or recurrent cancer of any organ, or current chemotherapy and/or radiation 
657 treatment.
658
659  States of immune compromise.
660
661  Collagen vascular or autoimmune disease. 
662
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663  Co-existing medical conditions or treatments that may increase the risk of complications, 
664 reduce the response to treatment, confound the interpretation of results, or which 
665 necessitatesan intervention with demonstrated effectiveness rather than experimental 
666 intervention.
667
668    Emotional or mental health concerns. 
669   
670    Elements of lifestyle such as smoking, physical activity, sun exposure, certain 
671  food/beverage consumption or restrictions that may impact the safety or effectiveness of 
672  the intervention. 
673   
674  Further inclusion and exclusion criteria should be determined by the study design and 
675 technological characteristicsof the device.
(4)Radiant Dose Selection
676
677 As with any energy delivery device, proper dose selection should be justified with testing or 
678 derived from known safety and effectiveness attributes given a specific wavelength or 
679 wavelengths of light energy. Dose selection should encompass irradiance, pulse width, pulse 
680 frequency, and duration of exposure. Dose selection may also be impacted by the subjects 
681 Fitzpatrick skin phototype disease severity, etc. We recommend that the choice of output settings 
682 and treatment schedule be justified and, when warranted,confirmed in pilot studies prior to 
683 initiation of pivotal studies. However, some dose selection could beattempted via use of 
684 adaptive design elements in the proposed clinical study. For more information, refer to FDA 
685 guidance Adaptive Designs for Medical Device Clinical Studies.35
(5)Study Endpoints
686
687 The study endpoints should be identified prior to study initiation. We recommend thefollowing 
688 be considered when selecting your study endpoint(s):
689
690  The characteristic that will be assessed (e.g.,hair growth, reduction in acne, improvement 
691 in periorbital wrinkles, reduction in circumference at a pre-specified location).
692
693  The metric that will be used, employing objective quantitative data when possible (e.g.,
694 hairs/cm2 or lesion count). Validated scales and patient reported outcomes can be used in 
695 conjunction with objective measures and as endpoints.36 For endpoints that involve 
696 observable changes, endpoints should quantify the change. The primary data, including 
697 physical measurements and photographs upon which the endpoints rely, are an integral 
698 part of the evaluation process and should be provided in your submission or made
699 available for review.
35 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/adaptive-designs-medical-device-
clinical-studies. 
36 FDA guidance Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome 
Instruments for Use in Medical Device Evaluation can be found at: https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/principles-selecting-developing-modifying-and-adapting-patient-
reported-outcome-instruments-use. 
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700
701   Criteria for success, per subject and per study (e.g., the increase in hair count that will 
702  define a subject as a responder, and the percent of responders that will define study 
703 success). 
704
705   The time at which endpoints are assessed. The time points at which evaluation is 
706  performed should be determined by the proposed indications for use, expected timeline 
707 for response, and known history of the target disorder. 
708
709   A measurement of safety as well as effectiveness. Safety endpoints will vary with the 
710  mechanism of the device. Since devices may be operated at variable parameters, both 
711  safety and effectiveness endpoints should be assessed across the spectrum of parameters 
712 that is expected to be employed in clinical use of the device. 
713
714   Device parameter ranges. Energy-based device treatments may produce dose-related 
715  responses. The inclusion of a range of treatment parameters may affect the choice or 
716  definition of endpoints, as well as the statistical analysis plan, the number of subjects 
717 enrolled, and the labeling. 
718
719   When endpoints include subjective outcomes, we strongly recommend that external 
720  observers who are blinded to the history of the treatment are utilized. We recommend the 
721  inclusion of three observers as it strengthens the data validity by reducing equivocal or 
722  contradictory scores. If proposing a study design that varies from this recommendation 
723 (e.g., fewer number of observers), we recommend you consult with the FDA. 
(6) Study Duration and Follow-Up Schedule
724
725  The duration of follow-up will depend on the indications for use. We recommend that the study 
726  duration and follow-up schedule be based on the anticipated interval needed to assess the 
727  durability of the response, as well as the duration and consequent effects of any adverse events, 
728 and the incidence of delayed adverse events.  
729
730  In the analysis of safety, follow-up schedules are best designed to detect both early (acute) and 
731  delayed adverse events. In the analysis of effectiveness, the duration and frequency of follow-up 
732 assessments depend on the known and/or expected tissue effects. 
733
734  Devices that are intended for ongoing or maintenance use may warrant different follow-up 
735 timelines for monitoring. 
(7) Statistical Considerations
736
737  We recommend that clinical studies for PBM devices be well designed with valid statistical 
738  analysis plans. The statistical analysis plan should be developed in conjunction with the study 
739 design to ensure the data set will be robust. For more information on design of statistical analysis 
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740 plans, we recommend you refer to FDA guidance titled Design Considerations for Pivotal 
741 Clinical Investigations for Medical Devices.37
(8)Adverse Event Monitoring 
742
743 We recommend that all adverse events related to PBM device procedures be recorded during the 
744 clinical study and reported in your submission in order to develop an accurate understanding of 
745 the risks and benefits of these devices.
746
M. Modifications
747
748 In accordance with 21 CFR 807.81(a)(3), a change or modification to a device in commercial 
749 distribution that could significantly affect the safety or effectiveness of the device or represents 
750 a major change or modification in the intended use of the device requires a new 510(k).The 
751 changes or modifications listed below would likely require submission of a new 510(k). Note 
752  that this list is not exhaustive but provides examples of modifications that FDA believes will 
753 generally require submission of a new 510(k). For additional details, see FDA guidances 
754  Deciding When to Submit a 510(k) for a Change to an Existing Device38 and Deciding When 
755 to Submit a 510(k) for a Software Change to an Existing Device.39
756
757 Such changes or modifications include:
758
759  Changes to the light source, circuitry,or power supply of the device  FDA considers 
760 thesechanges to be modifications in design and energy source. FDA has determined that 
761 thesechanges could significantly affect safetyof the device by changing laser safety, 
762 thermal safety (if the modifieddevice is generating heat),electrical safety, and EMC. 
763
764  Change in light output or treatment regimen  FDA considers this change to be a 
765 modification in design.FDA has determined that this change could significantly affect 
766 both safety and effectiveness of the device by altering light induced tissue effects.
767
768  Changing from prescription use to OTC use FDA considers this change to be a 
769 significant change. FDA has determined that this change could significantly affect both 
770 safety and effectiveness of the device by changing the use environment and intended 
771 user. 
772
773 FDA believes that the following changes ormodifications would likely not require submission of 
774 a new 510(k):
775
776  Cosmetic changes to the appearance of the device.
37 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-pivotal-
clinical-investigations-medical-devices. 
38 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-
existing-device. 
39 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-
software-change-existing-device.
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777
778   Changes to the labeling that do not affect the intended use, indications for use, or 
779 conditions of use. 
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Appendix A. Glossary of Terms 
780
781 The definitions listed here are for the purposes of this guidance:
782
783 Coherent: Waves that are in-phase with one another.
784
785 Fluence: Light energy received by a surface per unit area.
786
787  Gain Medium: The solid, liquid, or gaseous medium that is usually placed between two mirrors 
788  which is called an optical cavity. Gain medium is used to convert the energy from the pumping 
789 source to a laser beam. 
790
791 Irradiance: Light power received by a surface per unit area. 
792
793 Melanin: Natural pigments in the skin. 
794
795  PBM: Photobiomodulation, also known as low level light therapy (LLLT), is a therapeutic 
796 technique that uses low energy light to alter the function of the body.
797
798 Periorbital: Around the orbit of the eye.
799
800 Pulsed Laser: Any laser that delivers energy in pulses instead of a continuous wave. 
801
802   Pulse duration (in milliseconds): The length of time during which the instantaneous 
803 laser power is at least half the peak power.
804
805  Pulse shape: Square, Gaussian, Trapezoid, etc.
806
807  Energy per pulse (mJ): Energy delivered during a single pulse.
808
809  Fluence per pulse (mJ/cm2): Energy delivered per area per pulse during a single pulse. 
810
811  Duty cycle (%): The percentage of time the laser is on.
812
813  Repetition rate (Hz): Number of pulses delivered at each second. 
814
815  Laser beam profile: Circle, Line, Square, Gaussian, etc.
816
817 Pumping Source: The energy source used to amplify light in the gain medium. 
818
819 Skin Type: A scientific classification of human skin such as Fitzpatrick Skin Scale.
820
821  Wavelength: The distance between two successive wave crests; determines the color of the light 
822 in the visible spectrum. 
823
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Appendix B. Labeling Examples
824
825
826  The following provide examples of warnings and precautions for PBM devices that follow the 
827 recommendations provided in Section C. Labeling. 
Warnings
828
829   The long term effects of prolonged use of non-thermal laser exposure are unknown.
830
831  Safety of non-thermal lasers for use during pregnancy has not been established. 
832
833   Laser treatment should not be applied over, or in proximity to, cancerous lesions as 
834 conclusive tests have not been conducted.
835
836  Misuse of the device might lead to injury. 
837
Precautions
838
839    To eliminate any possible danger to the eyes, safety glasses must be worn by the patient 
840 during treatment.
841
842  Caution should be used over areas of skin that lack normal sensation. 
843
844  Use only with accessories recommended by manufacturer. 
845
846  Avoid the ingress of any liquid.
26