CYNOSURE PHOTOGENICA ER LASER

K973498 · Cynosure, Inc. · GEX · Nov 13, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973498
• Device Name: CYNOSURE PHOTOGENICA ER LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues. Typical applications include dermatology, plastic surgery, urology, gastrocnterology, neurosurgery, gynecology, arthroscopy, general surgery. ENT and ophthalmology.

Device Story

PhotoGenica Er Laser is a medical laser system used for soft tissue surgery and skin resurfacing. The device comprises a power supply, water cooling system, and optical bench. It operates at 20 pulses per second with a pulse energy of 2 Joules, delivering an average power of 20 watts. It is intended for use by clinicians in various specialties including dermatology, plastic surgery, and general surgery. The laser energy is applied to target tissues to perform incision, excision, ablation, or vaporization. The device provides a surgical tool for healthcare providers to treat patients requiring soft tissue management or dermatological resurfacing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Er:YAG laser system; 2.94 micron wavelength; 20 pulses per second; 2 Joules pulse energy; 20 watts average power. System consists of power supply, water cooling system, and optical bench.

Indications for Use

Indicated for skin resurfacing and incision, excision, ablation, or vaporization of soft bodily tissues in dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT, and ophthalmology.

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

• Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser

Submission Summary (Full Text)

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K97349P

| Submitter: | Cynosure, Inc.<br>10 Elizabeth Drive<br>Chelmsford, MA 01824 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NOV 13 1997 |
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | September 11, 1997 |
| Device Trade Name: | PhotoGenica Er Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device: | Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser |
| Device Description: | The PhotoGenica Er Laser consists of three interconnected sections:<br>the power supply, the water cooling system and the optical bench.<br>At 20 pulses per second and a pulse energy of 2 Joules, the average<br>power from the laser is 20 watts. |
| Intended Use: | Skin resurfacing and for the incision, excision, ablation or<br>vaporization of soft bodily tissues |
| Comparison: | The PhotoGenica Er Laser is substantially equivalent to the<br>Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser in<br>terms of treatment wavelength, pulse duration, pulse energy, and<br>biological effects. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica Er is another safe and effective laser for skin<br>resurfacing and for the incision, excision, ablation or vaporization<br>of soft bodily tissues. |
| Additional Information: | None requested at this time |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

NOV 1 3 1997

Re: K973498 Trade Name: CYNOSURE PhotoGenica ER Laser Regulatory Class: II Product Code: GEX Dated: September 12, 1997 Received: September 15, 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 requirements , 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 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.

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Page 2 - Mr. George Cho

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,

toscella

Cella 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):_K973498

Device Name: __ Cynosure PhotoGenica Er Laser___

Indications lior Usc:

The PhotoGenica Er laser is used for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues.

Typical applications include dermatology, plastic surgery, urology, gastrocnterology, neurosurgery, gynecology, arthroscopy, general surgery. ENT and ophthalmology.

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Concurrence of CDRH. Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K973418 |

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OK

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