A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris
Phase: NA
Conditions: Acne Vulgaris
Sponsor: Cutera Inc.

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
Confidential and Proprietary                                                                      Page 1  of 48                                                      
 16 APR 2021 
 
 
TITLE PAGE 
 
 
Protocol Number: 
C-20-PAC01 
Protocol Title: 
A Safety and Efficacy Study of a 1726nm Laser for the Treatment of 
Acne Vulgaris 
Sponsor: 
 
Cutera, Inc. 
3240 Bayshore Boulevard 
Brisbane, CA 94005 
 
 
 
 
 
 
 
 
 
  
 Dated April 16, 2021 
 
 
   
 
Statement of Compliance  
The study will be conducted in accordance with the design and specific provisions of this IRB approved protocol, in 
accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent 
with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).  
 
 
 
NOTE:  The confidential information in the following document is provided to you as an Investigator, potential Investigator, or 
consultant for review by you, your staff, applicable Institutional Review Board (IRB), and US Food and Drug Administration 
(FDA). By accepting this document, you agree that the information contained herein will not be disclosed to others, without 
written authorization from Cutera, Inc. except to the extent necessary to obtain informed consent/assent from those persons 
to whom the device will be administered. 
 
 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
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Protocol Signature Page – Principal Investigator 
 
 
PROTOCOL C-20-PAC01 
 
 
Study Title:   A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris  
 
 
 
 
 
I have received and read the protocol dated April 16, 2021 and agree to adhere to the requirements. I am 
aware that my adherence to the above protocol is mandatory and that any changes in the protocol or 
informed consent/assent form must first be approved by Cutera, Inc., the Institutional Review Board (IRB), 
and the US Food and Drug Administration (FDA) according to their policies except those changes necessary 
to eliminate apparent immediate hazards to subjects.  I will ensure copies of this protocol and all pertinent 
information are provided to the study personnel under my supervision.  I will ensure this material is 
discussed with them and they are fully informed regarding their role in the study. I will ensure that the 
study is conducted in compliance with the protocol, IRB guidelines, Good Clinical Practice (GCP), FDA 21 
CFR part 812 and all other applicable regulatory requirements. I agree to commence this study only after 
documented IRB and FDA approval is obtained. 
 
 
 
 
Principal 
Investigator 
 
 
 
 
 
 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
Printed Name 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
Confidential and Proprietary                                                                      Page 3  of 48                                                      
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Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
Confidential and Proprietary                                                                      Page 4  of 48                                                      
 16 APR 2021 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
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 16 APR 2021 
1 
PURPOSE 
The purpose of this pivotal investigation is to evaluate the safety and efficacy of the investigational 
Cutera® 1726 nm laser system (
 for the treatment of mild to severe acne vulgaris. 
Data from this investigation is intended to support a future 510(k) submission to obtain marketing 
clearance for the intended use listed above. 
2 
BACKGROUND INFORMATION 
2.1 
Acne Vulgaris 
Acne Vulgaris is one of the most common dermatological conditions and affects a significant number of 
adolescents and adults.1, 2, 3   It develops in the pilosebaceous units of the skin from the following four 
factors—excess sebum production, the presence of the Propionibacterium acnes (P. acnes) bacteria, 
follicular epidermal hyper proliferation that plugs the follicle, and inflammation. It can have severe 
psychological effects and can leave the patient with severe skin scarring.3, 4, 5, 6  
 
Currently, standard acne treatment includes the use of topical and systemic medications, with the choice 
of treatment often determined by disease severity, but also by patient preferences and cost 
considerations.5 
Topical treatments work to reduce the level of follicle obstruction and reduce the bacterial load and 
inflammation. Of the topical medications, retinoids, benzoyl peroxide, azelaic acid, salicylic acid, and 
antibiotic solutions are used regularly, either alone or in combination with other treatments. 
Combinations have been reported to increase effectiveness, especially with benzoyl peroxide or retinoids 
and topical antibiotics such as clindamycin, erythromycin, or tetracycline.  Topical retinoids are indicated 
as a first-line treatment in patients with non-inflammatory lesions.6  Because the use of topical antibiotics 
may lead to resistance in the P. acnes bacteria, the use of benzoyl peroxide, retinoids, and other non-
antibiotic medications are an important adjunct to antibiotic therapy. 3, 6 
Systemic medications include oral antibiotics, anti-androgens, and isotretinoin.  Oral antibiotics, among 
other potential mechanisms of action, target bacteria and directly reduce inflammation.  Oral anti-
androgens such as low estrogen oral contraceptives, are indicated after failure of standard antibiotic 
regimens, and act to reduce the sebum driving effects of testosterone. 5  Oral isotretinoin has remained 
the most effective systemic medication for moderate to severe acne as well as for refractory cases.  It acts 
to affect cell progression, differentiation, survival, and apoptosis, as well as reduces sebum production, 
comedogenesis, P. acnes load, and inflammation.5, 6, 7       
Each of these treatments has its limitations. For example, oral isotretinoin has serious side effects of 
teratogenicity and possibly psychiatric effects, which can limit the safety and utility of the drug for many 
patients.7 Although topical and oral antibiotics have been used successfully in the treatment of acne for 
decades, the concern over antibiotic resistance continues to grow.3 As such, alternative, yet effective new 
treatments are still needed. While topical and systemic medications remain the gold standard for 
treatment of acne vulgaris, laser therapy which has emerged in recent decades as an effective treatment 
of acne vulgaris may be an additional option for some patients, especially for those who cannot tolerate 
standard treatments or for refractory cases.6 
There are two main mechanisms of action for treatment of acne with light therapy. First, blue or red light 
sources, green or yellow light lasers, and intense pulsed light (IPL) devices kill P. acnes directly. Second, 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
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16 APR 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
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 16 APR 2021 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
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 16 APR 2021 
5 
STUDY POPULATION 
5.1 
Subject Recruitment and Selection 
Male or female subjects, ages 16 to 60, with Fitzpatrick Skin Type I-VI19 who present with mild, moderate, 
or severe facial acne vulgaris at baseline (and desire laser treatment for facial acne) will be included. 
Subjects will be recruited to participate from the local population. Subjects may also be recruited from 
the Investigator’s or study site’s existing patient database or from patients who present themselves to the 
study site requesting treatment. Only subjects who meet all eligibility criteria and who provide written 
informed consent/assent will be enrolled into the study. 
 
 
 
 
Each subject will be evaluated to assess his/her suitability for entry into the study according to the 
following inclusion and exclusion criteria.  
5.1.1 
Inclusion Criteria 
To be included in the study, subjects must meet all of the following Inclusion Criteria: 
 
1.  Female or Male, 16 to 60 years of age (inclusive). 
2.  
 Fitzpatrick Skin Type I-IV19; 
 Fitzpatrick Skin Type V-VI19 
3.  
Has clinically diagnosed acne vulgaris of severity grade 2 – 4 on the face 
 
 using the Investigator’s Global 
Assessment Scale 
  
4.  
Has 
 inflammatory acne lesions on the face as determined by the Investigator (or 
qualified designee). 
5.  Subject (and parent or legal guardian if subject is a minor under age 18) must be able to 
read, speak, and understand English and sign the Informed Consent Form. 
6.  
Willing to stop using topical retinoids and other acne medications for 1 month (30 days) 
prior to baseline and for the duration of the study. If the acne medication is topical, the 
washout applies to use on the face only.   
7.  Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment 
care instructions. 
8.  
Willing to have very limited sun exposure (including avoiding tanning booths, sun lamps, 
sunbathing) and use an approved sunscreen of SPF 30 or higher on the face every day for 
the duration of the study, including the follow-up period. 
9.  Willing to have photographs taken of the face and agree to the use of photographs for 
presentation, educational or marketing purposes. 
10.  Agree to not undergo any other procedure(s) or add any new treatment modalities in the 
target area during the study. 
5.1.2 
Exclusion Criteria 
Subjects will be excluded from the study if they meet any of the following Exclusion Criteria: 
 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
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 16 APR 2021 
1.  
Has clinically diagnosed acne vulgaris of severity grade 0 or 1 on the face 
 
using the Investigator’s Global 
Assessment Scale. 
2.  Prior treatment to the target area during participation in a clinical trial of another device or 
drug within 1 month (30 days) prior to study participation.  
3.  
Prior treatment to the target area within 3 months of study participation including chemical 
peel, dermabrasion, microneedling, radiofrequency treatment, laser or light-based 
procedures, cryodestruction or chemodestruction, intralesional steroids, photodynamic 
therapy, or acne surgery. 
4.  Prior injection of botulinum toxin in the target area within 3 months of study participation 
and for the duration of the study. 
5.  Prior injection of collagen, hyaluronic acid filler or other dermal filler in the target area 
within 6 weeks of study participation. 
6.  Systemic use of retinoid, such as isotretinoin, within 6 months of study participation. 
7.  History of malignant tumors in the target area. 
8.  Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with 
diagnosis or assessment of acne vulgaris in the target area (okay if shaved). 
9.  Pregnant and/or breastfeeding or planning to become pregnant during the study. 
10.  
Presence of any skin condition in the target area (e.g. eczema, psoriasis, dermatitis, rash, 
papulo-pustular rosacea, infection) that would interfere with the diagnosis or assessment of 
acne vulgaris. 
11.  
Any medical condition that, in the opinion of the Investigator, would interfere with patient’s 
participation in the full study protocol (e.g. severe Diabetes Mellitus or Cardiovascular 
Disease). 
12.  Suffering from diagnosed coagulation disorders or taking prescription anticoagulation 
medications.  
13.  History of diagnosed immunosuppression/immune deficiency disorders or currently using 
immunosuppressive medications.  
14.  History of diagnosed connective tissue disease, such as systemic lupus erythematosus or 
scleroderma.  
15.  Any use of medication that is known to increase sensitivity to light according to Investigator’s 
discretion. 
16.  History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster 
(shingles) in the target area, unless treatment is conducted following a prophylactic regimen. 
17.  History of radiation to the target area, currently undergoing treatment for skin cancer in the 
target area, or undergoing systemic chemotherapy for the treatment of cancer.  
18.  History of diagnosed pigmentary disorders (including vitiligo) in the target area. 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
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 16 APR 2021 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
Confidential and Proprietary                                                                      Page 24  of 48                                                      
 16 APR 2021 
7.4 
Recording AEs/SAEs and ADEs/SADEs 
All AEs/SAEs and ADEs/SADEs will be: (1) evaluated, monitored and tracked from the time of the first study 
treatment and (2) must be recorded in AE section of the protocol specific case report forms (CRFs). 
Medical occurrences that begin after enrolling into the study and before administration of study 
treatment will be recorded on the Medical History section of the CRF, not the AE section. 
 
At each contact with the subject, the Investigator must seek information on AEs/ADEs and SAEs/SADEs by 
specific questioning and, as appropriate, by examination. AEs/ADEs and SAEs/SADEs may be observed by 
the Investigator and/or clinical research staff, elicited from the subject and/or family member or 
volunteered by the subject. All observed and volunteered adverse signs and symptoms, anticipated or 
unanticipated, regardless of severity or frequency, will be recorded in the CRFs. Included in the description 
should be the nature of the sign or symptom (including location of the AE/ADE as applicable), the date of 
onset, date of resolution (duration), the severity, anticipated or unanticipated, the relationship to study 
treatment or other therapy, the action taken (if any), and the outcome.  
 
All SAEs/SADEs, anticipated or unanticipated, must be reported to the Sponsor as soon as possible (no 
later than 24 hours after occurrence).  The SAE/SADE must be recorded in: (1) the protocol-specific CRF 
and (2) a written report must be submitted to the Sponsor no later than ten (10) working days after the 
Investigator first learns of the event. The written report shall include a full description of the event and 
sequelae, in the format detailed by the Sponsor’s SAE/SADE Form.  Investigator may be required to submit 
additional reports to the IRB and to the Sponsor related to SAEs/SADEs. 
 
The Sponsor will immediately conduct an evaluation of any SAE/SADEs per 21 CFR part 812.46(b)(1).  If 
the SAE/SADE is determined to be a USADE, the Sponsor will report results of such evaluation to IRB, FDA 
and participating Investigators pursuant to 21 CFR part 812.150(b)(1).  If the Sponsor determines the 
USADE presents an unreasonable risk to subjects, the Sponsor will terminate the study or parts of the 
study presenting that risk pursuant to 21 CFR part 812.46(b)(2). 
7.5 
Follow-up of Subjects after AEs/ADEs 
All reported AEs/ADEs should be followed until resolution.  In the unusual circumstance that an AE/ADE 
has not resolved by the time of the subject’s completion of the study, an explanation will be entered on 
the appropriate CRF and the subject will be referred to his or her primary care provider (unless specified 
otherwise by the sponsor). Resolutions of events and all events that result in permanent discontinuation 
from this clinical trial are to be documented on the appropriate CRFs. 
7.6 
Pregnancy Reporting 
Any pregnancy which comes to the attention of the Investigator during the study must be reported to the 
Sponsor and the IRB as soon as the Investigator or study staff becomes aware of the pregnancy. Subjects 
who become pregnant during the study will be required to discontinue treatment immediately and be 
discontinued from the study 
  Subject will be followed until completion of pregnancy. 
Pregnancy itself is not considered an AE/ADE.  A congenital anomaly or birth defect will be reported as an 
SAE. 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
Confidential and Proprietary                                                                      Page 25  of 48                                                      
 16 APR 2021 
 
 
 
   
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.2 
Potential Benefits 
The subjects may or may not benefit from the study device. Potential benefit of laser treatment is 
reduction in number and/or severity of acne lesions. There is no guarantee of success.  
9 
RISK MANAGEMENT 
Appropriate risk mitigation measures have been taken to support exposure of these patients to the 
investigational device, as described below. 
The Investigators participating in this study will be chosen based on medical specialty, experience 
diagnosing and treating acne vulgaris, experience conducting clinical research studies and experience in 
the use of laser-based devices for aesthetic indications and/or dermatology applications. 
 
In addition, all study Investigators (and qualified designees) will be trained on the use of the investigational 
Cutera® 1726 nm laser system by a representative of the Sponsor. 
 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
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 16 APR 2021 
Paired t-test if the differences are normally distributed, or non-parametrically using the Sign-Rank Test if 
the differences are not normally distributed.  Mid study evaluation of data may be performed to facilitate 
clinical study report writing. Investigators and panelists will remain blinded to such evaluation. 
Appropriate statistical software will be used to perform all analyses. Exact confidence intervals will be 
generated for estimates of proportions.  Asymptotic confidence intervals will be generated for estimates 
of means.  Except where otherwise noted, the p-values of all tests will be reported without any correction 
for the multiplicity of tests performed. 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
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12 
  STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES  
12.1  Training  
The Investigator(s) and site research staff will be trained on the study procedures. Sponsor 
representative(s) may be present at the site during the treatments to ensure that all procedures and 
documentation are in place. 
12.2 Monitoring 
Investigator will allow sponsor representatives to periodically review the study documentation.  
Monitor(s), qualified by training and experience and selected by the Sponsor, will monitor the 
participating Investigators, investigational sites and study documentation at regular intervals per the 
Sponsor’s standard operating procedures (SOPs), and in compliance with recognized Good Clinical 
Practices (GCP), FDA’s IDE guidance documents, and as outlined in 21 C.F.R. § 812.43(d) and 21 C.F.R. 
§812.46.  The major function of the clinical monitor(s) is to observe and assess compliance of the 
investigators and investigational sites with the requirements of this clinical study protocol and GCP.  
Overall, the monitor’s duties include, but are not limited to study site visits and review of clinical study 
documents and results, which consists of monitoring subject specific consents and case report forms 
(including source documents as applicable), assessing protocol adherence, ensuring ongoing 
implementation of required data entry, ensuring ongoing implementation of quality control procedures, 
and ensuring general adherence to GCP requirements.  The monitor(s) will operate under written 
procedures to ensure compliance with the protocol. 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
Confidential and Proprietary                                                                      Page 32  of 48                                                      
 16 APR 2021 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
Confidential and Proprietary                                                                      Page 33  of 48                                                      
 16 APR 2021 
12.3 Informed Consent/Assent 
The Investigator is responsible for ensuring that written informed consent, using an FDA and IRB approved 
informed consent document, is obtained from each subject before the performance of any protocol 
procedures, including administration of the study device.  
 
The informed consent document must comply with all essential elements as defined in 21 CFR part 50, 
with consideration given to the guidelines set forth in International Conference on Harmonization (ICH)  
Good Clinical Practice, the Health Insurance Portability and Accountability Act (HIPAA), as well as other 
application regulatory requirements  and must contain a statement that consent is freely given, the study 
involves research, the subject is aware of the risks and benefits of entering the study, the subject will be 
informed of any significant new findings that may affect the subject’s willingness to participate in the 
study and that the subject is free to withdraw from the study at any time.  Minor subjects under the age 
of 18 and one parent or legal guardian must provide written informed consent, including an assent for 
minors, prior to being enrolled in the study. An evaluation of each candidate will be conducted by the 
Investigator (or qualified designee). Upon determining a subject’s eligibility status, the subject will be 
offered the opportunity to participate in the study. 
 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
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 16 APR 2021 
12.4 Protocol Compliance 
The Investigator must comply with all terms of the protocol.   
12.4.1 Protocol Amendments 
Neither the Investigator nor the Sponsor will modify, alter, or amend this protocol without first obtaining 
the concurrence of the other party (with the exception of modifications which involve mitigating a medical 
emergency or immediate health risk to the subject). IRB and FDA approval must be obtained before 
implementation of an amendment according to IRB and FDA policies.  
12.4.2  Protocol Deviations 
All protocol deviations must be clearly described on the appropriate case report form. Deviations from 
the protocol may include but are not limited to the subject’s failure to attend a scheduled visit during a 
visit window and incomplete or incorrect study procedures. A deviation to protect the life or physical well-
being of a subject in an  emergency must be reported to the Sponsor as soon as possible (but no later than 
within 5 working days after the emergency occurred or sooner if required by IRB policies).  Except in such 
an emergency, prior approval by the Sponsor is required for changes in or deviations from a plan. If a 
deviation does not obtain prior approval from the Sponsor, it must be reported to the Sponsor within 24 
hours of the deviation occurring. If a deviation is considered a necessary change to the protocol or likely 
to reoccur, the Sponsor should initiate an amendment to the protocol to reflect the change. If these 
changes or deviations have potential to affect the scientific soundness of the plan, the risk/benefit ratio 
of the study, or the rights, safety or welfare of human subjects, prior approval by FDA and IRB in 
accordance with 21 CFR 812.35 (a) is also required.  
 
All deviations, including minor or administrative deviations, must be reported to the Sponsor. Significant 
protocol deviations must be reported to IRB according to their policies. 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
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12.5 Study Personnel 
Prior to the start of the study, the Investigator must supply the Sponsor with a list of the names and 
curricula vitae that describe the professional backgrounds of the clinically responsible study Investigators 
(principal, sub-investigators), research nurses, coordinators and other possible participants (e.g. medical 
doctor, nurse, etc.). 
12.6 Disclosure of Financial Interest 
Each Investigator [principal and sub-investigator(s)] is required to disclose sufficient accurate financial 
information to the Sponsor on the provided form, to allow sponsor to submit complete and accurate 
certification or disclosure statements as required under 21 CFR part 54. Each Investigator shall promptly 
update this information and inform the Sponsor if any relevant changes occur during the course of the 
study and for 1 year following completion of the study as required under 21 CFR part 812.100(d).  
12.7 Clinicaltrials.gov Posting 
This study will be posted on clinicaltrials.gov by the Sponsor per the Sponsor’s SOP and applicable 
regulations. 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
Confidential and Proprietary                                                                      Page 36  of 48                                                      
 16 APR 2021 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
Confidential and Proprietary                                                                      Page 37  of 48                                                      
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13 
 SUBJECT CONFIDENTIALITY 
This study preserves the confidentiality of all subjects under the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) Privacy Rule. The following safeguards will be in place to protect the 
privacy of the individuals who are the subjects of the health information to be used in the research and 
the confidentiality of that information:   
 
The subjects will be informed by the Investigator or the qualified designee that their medical records (and 
other identifying study documents) will be kept as confidential as possible but may be subject to review 
and copy by: (1) the Sponsor, or its representative; (2) reviewing IRB; and/or (3) by appropriate regulatory 
bodies (e.g. the US Food and Drug Administration (FDA), Department of Health and Human Services 
(DHHS) agencies).  

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
Confidential and Proprietary                                                                      Page 38  of 48                                                      
 16 APR 2021 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
Confidential and Proprietary                                                                      Page 39  of 48                                                      
 16 APR 2021 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
Confidential and Proprietary                                                                      Page 40  of 48                                                      
 16 APR 2021 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
 
Confidential and Proprietary 
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 16 APR 2021 

Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
 
Confidential and Proprietary 
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Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
 
Confidential and Proprietary 
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Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
 
Confidential and Proprietary 
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Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
 
Confidential and Proprietary 
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Cutera, Inc. 
Protocol # C-20-PAC01 
“A Safety and Efficacy Study of a 1726nm Laser for the Treatment of Acne Vulgaris” 
 
 
Confidential and Proprietary 
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