[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Notices]
[Pages 20992-20993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8945]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0189]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Low Level Laser System for 
Aesthetic Use; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: Low Level Laser System for Aesthetic Use.'' This 
guidance document describes a means by which low level laser systems 
for aesthetic use may comply with the requirement of special controls 
for class II devices. Elsewhere in this issue of the Federal Register, 
FDA is publishing a final rule to classify low level laser systems for 
aesthetic use into class II (special controls). This guidance document 
is being immediately implemented as the special control for low level 
laser systems for aesthetic use, but it remains subject to comment in 
accordance with the Agency's good guidance practices.

DATES: Submit either electronic or written comments on the guidance at 
any time. General comments on Agency guidances are welcome at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Class II Special Controls Guidance Document: Low 
Level Laser System for Aesthetic Use'' to the Division of Small 
Manufacturers, International, and Consumer Assistance, Office of 
Communication, Education and Radiation Programs, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

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. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying low level laser systems for aesthetic use into 
class II (special controls) under section 513(f)(2) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(2)). 
This guidance document will serve as the special control for low level 
laser systems for aesthetic use. 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 (21 U.S.C. 360(k)) for a device that has 
not previously been classified may, within 30 days after receiving an 
order classifying the device in 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 shall, within 60 days 
of receiving such a request, classify the device by written order. This 
classification shall 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 such 
classification. Because of the timeframes established by section 
513(f)(2) of the FD&C Act, FDA has determined, under Sec.  10.115(g)(2) 
(21 CFR 10.115(g)(2)), that it is not feasible to allow for public 
participation before issuing this guidance as a final guidance 
document. Thus, FDA is issuing this guidance document as a level 1 
guidance document that is immediately in effect. FDA will consider any

[[Page 20993]]

comments that are received in response to this notice to determine 
whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on low level laser systems for aesthetic use. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Class II Special Controls Guidance Document: Low Level Laser System 
for Aesthetic Use,'' you may either send an e-mail request to 
<a href="/cdn-cgi/l/email-protection#3f5b4c52565c5e7f595b5e1157574c11585049"><span class="__cf_email__" data-cfemail="1f7b6c72767c7e5f797b7e3177776c31787069">[email protected]</span></a> to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1735 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; and the collections of information in 21 CFR 801 have 
been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8945 Filed 4-13-11; 8:45 am]
BILLING CODE 4160-01-P


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