CYNOSURE PHOTOGENICA 532 LASER

K974900 · Cynosure, Inc. · GEX · Feb 27, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974900
• Device Name: CYNOSURE PHOTOGENICA 532 LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PhotoGenica 532 laser is indicated for the treatment of benign cutaneous vascular and pigmented lesions.

Device Story

PhotoGenica 532 is a continuous wave (CW), frequency-doubled Nd:YAG laser system operating at 532 nm. Device delivers 4 watts CW output for dermatological procedures. System includes a 670 nm diode aiming beam and selectable exposure times ranging from 0.02 seconds to continuous. Operated by a physician via footswitch activation. Used in clinical settings for the treatment of vascular and pigmented skin lesions. Laser energy targets specific chromophores in the skin to achieve therapeutic effects. System is air-cooled and portable, weighing 25 lbs.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Frequency-doubled Nd:YAG laser; 532 nm wavelength; 4W CW output; 670 nm diode aiming beam; air-cooled by fans; 120/230 VAC power; footswitch-controlled; various spot diameter handpieces (0.2-1.5 mm).

Indications for Use

Indicated for the treatment of benign cutaneous vascular and pigmented lesions of the skin 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.

Predicate Devices

• American Medical Laser Nuvo-Lase 660 Laser

Submission Summary (Full Text)

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K974900

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## 510(K) Summary FEB 2 7 1998

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| Submitter: | Cynosure, Inc.<br>10 Elizabeth Drive<br>Chelmsford, MA 01824 |
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| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | December 24, 1997 |
| Device Trade Name: | PhotoGenica 532 Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device: | American Medical Laser Nuvo-Lase 660 Laser |
| Device Description: | The PhotoGenica 532 Laser is a CW, frequency-doubled Nd:YAG<br>laser system with a wavelength at 532 nm. The treatment beam output<br>for the PhotoGenica 532 is 4 watts CW at 532 nm. |
| | The aiming beam is provided by 5 mW, 670 nm diode laser. Exposure<br>times for the PhotoGenica 532 (in seconds) are 0.02, 0.05, 0.1, 0.25,<br>0.5, 1.0 and continuous. |
| | Laser activation is by a footswitch. Overall weight of the unit is 25 lb<br>(11 kg). |
| | Electrical power requirement is 120/230 VAC ±10%, 5/3 Amps, 50-60<br>Hz. The system is air-cooled by fans. |
| | Accessories available for use with the PhotoGenica 532 include 0.2,<br>0.5, 0.7, 1.0 and 1.5 mm (spot diameter) handpieces. |
| Intended Use: | The PhotoGenica 532 Laser system is indicated for the treatment of<br>vascular and pigmented lesions of the skin. |
| Comparison: | The PhotoGenica 532 Laser is substantially equivalent to the Nuvo-<br>Lase 660 Laser in terms of treatment wavelength, pulse duration,<br>power, and biological effects. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica 532 Laser is another safe and effective way to treat vascular or pigmented lesions of the skin. |
| Additional Information: | None requested at this time |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 1998

Mr. George Cho Senior Vice President Cynosure, Incorporated 10 Elizabeth Drive Chelmsford, Massachusetts 01824

Re : K974900 Cynosure PhotoGenica 532 Laser Trade Name: Regulatory Class: II Product Code: GEX 1997 Dated: December 24, December 30, 1997 Received:

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 The general controls provisions of the Act 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 Requlations, 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.

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Page 2 - Mr. Cho

This letter will allow you to beqin 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,

Witten, Ph.D., M.D. Celi a M. 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):

Device Name: _ Cynosure PhotoGenica 532 Laser

Indications For Use:

The PhotoGenica 532 laser is indicated for the treatment of benign cutaneous vascular and pigmented lesions.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Om)
Division of General Restorative Devices K974900
510(k) Number

Over-The-Counter Use_