[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Rules and Regulations]
[Pages 20840-20842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8944]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2011-N-0188]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Low Level Laser System for Aesthetic Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the low 
level laser system for aesthetic use into class II (special controls). 
The special control(s) that will apply to the device is entitled 
``Class II Special Controls Guidance Document: Low Level Laser System 
for Aesthetic Use.'' The Agency is classifying the device into class II 
(special controls) in order to provide a reasonable assurance of safety 
and effectiveness of the device. Elsewhere in this issue of the Federal 
Register, FDA is announcing the availability of a guidance document 
that will serve as the special control for this device type.

DATES: This rule is effective May 16, 2011. The classification was 
effective on August 24, 2010.

FOR FURTHER INFORMATION CONTACT: Richard Felten, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1436, Silver Spring, MD 20993-0002, 301-796-6392.

SUPPLEMENTARY INFORMATION:

I. What is the background of this rulemaking?

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    Section 513(f)(2) of the FD&C Act provides that any person who 
submits a premarket notification under section 510(k) of the FD&C Act 
for a device that has not previously been classified may, within 30 
days after receiving an order classifying the device into class III 
under section 513(f)(1) of the FD&C Act, request FDA to classify the 
device under the criteria set forth in section 513(a)(1) of the FD&C 
Act. FDA will, within 60 days of receiving this request, classify the 
device by written order. This classification will be the initial 
classification of the device. Within 30 days after the issuance of an 
order classifying the device, FDA must publish a notice in the Federal 
Register announcing this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on

[[Page 20841]]

December 22, 2008, classifying the Erchonia Low Level Laser System for 
Aesthetic Use into class III because it was not substantially 
equivalent to a device that was introduced or delivered for 
introduction into interstate commerce for commercial distribution 
before May 28, 1976, or a device which was subsequently reclassified 
into class I or class II. On January 5, 2009, Erchonia, Inc., submitted 
a petition requesting classification of the Erchonia Low Level Laser 
System for Aesthetic Use under section 513(f)(2) of the FD&C Act. The 
manufacturer recommended that the device be classified into class II. 
(Ref. 1)
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the petition in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act. FDA 
classifies devices into class II if general controls by themselves are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the petition, FDA determined that the device 
can be classified into class II with the establishment of special 
controls. FDA believes these special controls will provide reasonable 
assurance of the safety and effectiveness of the device.
    The device is assigned the generic name Low Level Laser System for 
Aesthetic Use, and it is identified as a device using low level laser 
energy for the disruption of adipocyte cells within the fat layer for 
the release of fat and lipids from these cells for noninvasive 
aesthetic use.
    FDA has identified the following risks to health associated 
specifically with this type of device and the recommended measures to 
mitigate these risks.
    <bullet> Ocular injury is a recognized hazard from laser optical 
systems because of the unique physical characteristics of laser light; 
that is, this optical radiation is easily transmitted into the eye as a 
very bright, intense light beam that may produce lesions on the retina. 
This hazard is addressed by device labeling, which includes 
recommendations for not looking directly at the laser beam and the 
wearing of appropriate laser safety eyewear by both the user and 
patient. The labeling also includes information defining the size of 
the area within which this optical hazard exists.
    <bullet> Electrical shock is addressed by recommended testing of 
the device according to recognized U.S. and international standards 
specifically designed to determine and measure potential electrical 
safety. Again, the recommended device labeling also includes specific 
warnings for the user in terms of device placement, appropriate 
electrical wiring needs, reminders to periodically check device wiring 
and accessories for damage, and avoidance of use of the device in 
environments where electrical shock is possible.
    <bullet> Unintended cell damage is a potential risk from use of low 
level lasers if improper or incorrect energy is used to initiate the 
process of causing lipid and fat leakage from the target adipocyte 
cells. The intended effect on the adipocyte cells is the creation of 
pores that results in the lipid or fat leaving these specialized cells; 
however, if the laser parameters are not correct, no effect may occur 
in terms of adipocyte change or other non-adipocyte cells may be 
affected, resulting in alteration of other cellular membranes or 
transport systems that could result in unintended cell death.
    <bullet> Use error represents those risks to the patient that can 
occur from improper use of the device. In order to address this 
potential risk, we recommend the manufacturer provide a detailed 
operator manual, which contains information on possible risks and 
hazards and how these should be avoided and clear recommended safe 
treatment procedures that include information on device settings for 
treatment, clear information on how the device is to be used during 
treatment, and recommended posttreatment care.
    FDA believes that the class II special controls guidance document 
will aid in mitigating the potential risks to health as described in 
table 1 of this document.

            Table 1--Risks to Health and Mitigation Measures
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            Identified risk              Recommended mitigation measures
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Ocular Injury..........................  Section 6. Bench Testing.
                                         Section 7. Software Validation.
                                         Section 8. Clinical Testing.
                                         Section 12. Labeling.
Electrical Shock.......................  Section 11. Electrical and
                                          Mechanical Safety Performance
                                          Testing (IEC 60601-1).
                                         Section 12. Labeling.
Unintended Cell Damage.................  Section 6. Bench Testing.
                                         Section 7. Software Validation.
                                         Section 8. Clinical Testing.
                                         Section 9. Biocompatibility.
                                         Section 10. Electromagnetic
                                          Compatibility (IEC 60601-1-2).
                                         Section 12. Labeling.
Use Error..............................  Section 12. Labeling.
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    FDA believes that the special controls guidance, ``Low Level Laser 
System for Aesthetic Use,'' in addition to general controls, address 
the risks to health and provide reasonable assurance of the safety and 
effectiveness of the device. Therefore, on August 24, 2010, FDA issued 
an order to the petitioner classifying the device into class II. FDA is 
codifying the classification of the device by adding Sec.  878.5400.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for low level laser 
system for aesthetic use will need to address the issues covered in the 
special controls guidance. However, the firm need only show that its 
device meets the recommendations of the guidance or in some other way 
provides equivalent assurance of safety and effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act, if FDA determines that premarket notification 
is not necessary to provide reasonable assurance of the

[[Page 20842]]

safety and effectiveness of the device. For this type of device, FDA 
has determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the low level laser system for 
aesthetic use they intend to market.

II. What is the environmental impact of this rule?

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. What is the analysis of impacts of this rule?

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive 
Order 12866 directs Agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The Agency believes that 
this final rule is not a significant regulatory action as defined by 
the Executive order and so it is not subject to review under the 
Executive order.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because reclassification of this device from class 
III to class II will relieve manufacturers of the device of the cost of 
complying with the premarket approval requirements of section 515 of 
the FD&C Act (21 U.S.C. 360e), and may permit small potential 
competitors to enter the marketplace by lowering their costs, the 
Agency certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $135 million, using the most current (2009) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Does this rule have federalism implications?

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive order 
requires Agencies to ``construe * * * a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts certain state requirements ``different from or in 
addition to'' certain Federal requirements applicable to devices. (See 
section 521 of the FD&C Act (21 U.S.C. 360k); See Medtronic, Inc., v. 
Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, Inc., 128 S. Ct. 
999 (2008)). The special controls established by this final rule 
creates ``requirements'' for specific medical devices under 21 U.S.C. 
360k, even though product sponsors have some flexibility in how they 
meet those requirements. (See Papike v. Tambrands, Inc., 107 F.3d 737, 
740-42 (9th Cir. 1997)).

V. How does this rule comply with the Paperwork Reduction Act of 1995?

    FDA concludes that this final rule contains no new collections of 
information. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3520) is not required. This final rule establishes as special 
controls a guidance document that refers to previously approved 
collections of information found in other FDA regulations. These 
collections of information are subject to review by OMB under the PRA. 
Elsewhere in this issue of the Federal Register, FDA is issuing a 
notice announcing the availability of the guidance document entitled 
``Class II Special Controls Guidance Document: Low Level Laser System 
for Aesthetic Use'' that will serve as the special control for this 
device. This notice contains an analysis of the paperwork burden for 
the guidance document.

VI. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Erchonia, Inc., January 5, 2009.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Section 878.5400 is added to subpart F to read as follows:


Sec.  878.5400  Low Level Laser System for Aesthetic Use

    (a) Identification. A Low Level Laser System for Aesthetic Use is a 
device using low level laser energy for the disruption of adipocyte 
cells within the fat layer for the release of fat and lipids from these 
cells for noninvasive aesthetic use.
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA guidance document entitled 
``Guidance for Industry and Food and Drug Administration Staff; Class 
II Special Controls Guidance Document: Low Level Laser System for 
Aesthetic Use.'' See Sec.  878.1(e) for the availability of this 
guidance document.

    Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8944 Filed 4-13-11; 8:45 am]
BILLING CODE 4160-01-P