CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER

K965128 · Cynosure, Inc. · GEX · Jul 14, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K965128
• Device Name: CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PhotoGenica VLV laser is used for the treatment of benign cutaneous vascular and vascular dependent lesions.

Device Story

The Cynosure PhotoGenica VLV is a cutaneous vascular lesion laser. It delivers laser energy to target and treat benign vascular and vascular-dependent skin lesions. Operated by a physician in a clinical setting, the device provides a therapeutic modality for dermatological conditions. The laser output is applied directly to the skin to achieve clinical outcomes through photothermolysis. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Cutaneous vascular lesion laser; energy source is laser radiation; intended for clinical use; device classification is Class II (Product Code GEX).

Indications for Use

Indicated for the treatment of benign cutaneous vascular and vascular dependent lesions in patients requiring laser therapy.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. George Cho
Senior Vice President
Cynosure, Inc.
35 Wiggins Avenue
Bedford, Massachusetts 01730-2314

JUL 14 1997

Re: K965128
Trade Name: Cynosure PhotoGenica VLV Cutaneous Vascular Lesion Laser
Regulatory Class: II
Product Code: GEX
Dated: April 30, 1997
Received: May 1, 1997

Dear Mr. Cho:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug

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Page 2 - Mr. George Cho

Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the *Federal Register*. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Number (if known): K965128

Device Name: Cynosure PhotoGenica VLV Cutaneous Vascular Lesion Laser

Indications For Use:

The PhotoGenica VLV laser is used for the treatment of benign cutaneous vascular and vascular dependent lesions.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐
(Optional Format 1-2-96)