CYNOSURE CO3 ER:YAG LASER

K983034 · Cynosure, Inc. · GEX · Sep 10, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K983034
• Device Name: CYNOSURE CO3 ER:YAG LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 10, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cynosure CO3 Er: Y AG 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, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.

Device Story

Cynosure CO3 Er:YAG Laser is a medical laser system consisting of a power supply, water cooling system, and optical bench. It functions by delivering laser energy to target soft tissues for surgical procedures such as incision, excision, ablation, or vaporization, and for skin resurfacing. The device is intended for use by trained clinicians in various surgical and clinical settings. By providing precise tissue interaction, the laser facilitates controlled removal or modification of soft tissue, offering a therapeutic benefit for dermatological and surgical applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Er:YAG laser system; consists of power supply, water cooling system, and optical bench. Operates as a surgical laser for soft tissue ablation and skin resurfacing.

Indications for Use

Indicated for skin resurfacing and incision, excision, ablation, or vaporization of soft bodily tissues across specialties including 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

• Cynosure PhotoGenica ER Laser

Submission Summary (Full Text)

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## Қ983034

## SEP 1 0 1998

:

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## 510(K) Summary

| Submitter: | Cynosure, Inc.<br>10 Elizabeth drive<br>Chelmsford, MA 01824 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | August 27, 1998 |
| Device Trade name: | Cynosure CO3 Er: Y AG Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device | Cynosure PhotoGenica ER Laser |
| Device description: | The CO3 Er:YAG Laser consists of three<br>interconnected sections: the power supply, the<br>water cooling system and the optical bench. |
| Intended Use: | Skin resurfacing and for the incision, excision<br>ablation or vaporization of soft bodily tissues. |
| Comparison: | The CO3 Er:YAG Laser is substantially<br>equivalent to the Cynosure PhotoGenica ER<br>Laser in terms of treatment wavelength, pulse<br>duration, pulse energy, and biological effects. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Cynosure CO3 Er: Y AG Laser is another safe<br>and effective laser for skin resurfacing and for the<br>incision, excision, ablation or vaporization of soft<br>bodily tissues. |
| Additional Information: | None requested at this time. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image. The logo is printed in black ink on a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1998

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

Re: K983034 Trade Name: Cynosure CO3 Er:YAG Laser Regulatory Class: II Product Code: GEX Dated: August 27, 1998 Received: August 31, 1998

## 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 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. 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 vour 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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): Je 9 3 3 4

Device Name: Cynosure CO3 Er:YAG Laser

Indications For Use:

The Cynosure CO3 Er: YAG 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, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use **__**

(Division Sign-Off)

(Optional Format 1-2-96)
Division of General Restorative Devices 983034

510(k) Number -