(90 days)
The Cynosure PhotoGenica VL laser is indicated for use in Dermatological and Plastic Surgery applications and the treatment of periocular wrinkles.
The PhotoGenica VL is a pulse-dye laser, having the organic dye as the lasing medium. It is a pulsed laser with a wavelength of 580 to 590nm. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD). Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.
The provided text is a 510(k) Summary for the PhotoGenica VL Medical Laser System. This document explicitly states:
- "Nonclinical Performance Data: none"
- "Clinical Performance Data: none"
Therefore, there is no information available within this document to describe acceptance criteria or a study that proves the device meets any such criteria. The device's substantial equivalence was based on its similarity to a predicate device (NLite Laser by ICN Pharmaceuticals, Inc.) regarding its indication for uses, principle of operation, wavelength, and pulse energy range, rather than performance studies demonstrating effectiveness against specific criteria.
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NOV 1 9 2001
510(k) SUMMARY
KO12806 Cynsoure, Inc. Submitter: 10 Elizabeth Drive Chelmsford, MA 01824 Contact: George Cho Senior Vice President of Medical Technology August 17, 2001 Date Summary Prepared: PhotoGenica VL Device Trade Name: Medical Laser System Common Name: Instrument, surgical, powered, laser Classification Name: 79-GEX 21 CFR 878.48 NLite Laser by ICN Pharmaceuticals, Inc. Equivalent Device: The PhotoGenica VL is a pulse-dye laser, having the Device Description: organic dye as the lasing medium. It is a pulsed laser with a wavelength of 580 to 590nm. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD). Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase. The PhotoGenica VL is indicated for treatment of Intended Use: periocular wrinkles and dermatological lesions. The PhotoGenica VL laser has an equivalent indication Comparison: for uses, the same principle of operation, the same wavelength and pulse energy range as the predicate devices. Nonclinical Performance Data: none Clinical Performance Data: none The PhotoGenica VL Laser is another safe and effective Conclusion:
Additional Information:
none
device for dermatologic applications.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2001
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K012806
Trade/Device Name: PhotoGenica VL Dermatology Laser Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Regulatory Class: II Product Code: GEX Dated: August 17, 2001 Received: August 21, 2001
Dear Mr. Cho:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. .
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Page 2 - Mr. George Cho
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
O
Sincerely yours,
Susan Walker, MS
Image /page/2/Picture/5 description: The image shows a signature. The signature is in black ink and appears to be cursive. The signature is illegible, but it appears to be a stylized version of the letters 'L' and 'e'.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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501(k) Number (if known):
KO12806
Device Name:
Cynosure PhotoGenica VL
Indications For Use:
The Cynosure PhotoGenica VL laser is indicated for use in Dermatological and Plastic Surgery applications and the treatment of periocular wrinkles.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
Susan Walk
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012806
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.