CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER

K992084 · Cynosure, Inc. · GEX · Jul 12, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992084
• Device Name: CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 12, 1999
• Decision: SESE
• Submission Type: Special
• 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.

Device Story

Cynosure SureScan with CO3 Er:YAG Laser is a medical laser system comprising a power supply, water cooling system, and optical bench. It delivers laser energy to target soft bodily tissues for resurfacing, incision, excision, ablation, or vaporization. Operated by physicians in clinical settings, the device provides precise tissue interaction via Er:YAG laser technology. The system allows clinicians to perform surgical procedures across multiple specialties, including dermatology and plastic surgery, by vaporizing or cutting tissue. The device benefits patients by providing a controlled method for skin resurfacing and soft tissue surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical laser system consisting of power supply, water cooling system, and optical bench. Utilizes Er:YAG laser technology for tissue ablation/vaporization. No specific materials or software algorithm details provided.

Indications for Use

Indicated for skin resurfacing and the incision, excision, ablation, or vaporization of soft bodily tissues in clinical 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 CO3 Er:YAG Laser

Submission Summary (Full Text)

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K992084

## 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: | June 18, 1999 |
| Device Trade name: | Cynosure SureScan with the CO3 Er:YAG Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device | Cynosure CO3 Er:YAG Laser |
| Device description: | The SureScan with the CO3 Er:YAG Laser<br>consists of three interconnected sections: the<br>power supply, the water cooling system and the<br>optical bench. |
| Intended Use: | Skin resurfacing and for the incision, excision<br>ablation or vaporization of soft bodily tissues. |
| Comparison: | The SureScan with the CO3 Er:YAG Laser is<br>substantially equivalent to the Cynosure CO3<br>Er:YAG Laser in terms of treatment wavelength,<br>pulse duration, pulse energy, and biological<br>effects. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Cynosure SureScan with the CO3 Er:YAG<br>Laser is another safe and effective laser for skin<br>resurfacing and for the incision, excision, ablation<br>or vaporization of soft bodily tissues. |
| Additional Information: | None requested at this time. |

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Public Health Service

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 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 in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 17 1999

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

K992084 K992084
Trade Name: Cynosure SureScan with the CO3 Er: YAG Laser
Trade Name: Cynosure SEV Re: Regulatory Class: GEX Product Code: II Dated: June 18, 1999 Received: June 21, 1999

Dear Mr. Cho:

1941 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 We have reviewed your Section 510(k) notification of manter and above and we have determined the devices markets in interstate commerce prior to use stated in the enclosure) to devices marketed in increasing to to devices that May 28, 1976, the enacment date of the Medical Device Finishaleral Food, Drug, and have been reclassified in accordance with the provisions of the general controls
Cosmetic Act (Act). You may, therefore, market the device, subject to the generals for Cosmetic Act (Act). You may, therefore, market the Act include requirements for
provisions of the Act. The general controls provisions of the Act include requirements for provisions of the Act. The general controls provisions of the Active, labeling, and
annual registration, listing of devices, good manufacturing practice, labeling, and annual registration, fisting of active, or active, and adulteration.
Prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
n and the success of the chiest to such additional controls. Existing major If your device is classified (see above) into entrols. Existing major
(Premarket Approval), it may be subject to such additional controls. Existing major (Premarket Approval), it may be subject to such additions. The Code of Federal Regultions, Title 21.
regulations affecting your device can be found in the Code of Federal in regulations affecting your device can be found in the coon assumes compliance with the
Parts 800 to 895. A substantially equivalent determination assumes county System Parts 800 to 895. A substantially equirement, as set forth in the Quality System
current Good Manufacturing Practice requirement, as set forth in the Quality System current Good Manufacturing Practice requirences: Gencral regulation (21 CFR Part 820) and that,
Regulation (QS) for Medical Devices: Gencral regulation (21 CFR Parts of the Regulation (QS) for Medical Devices: Gentelar (viri tration (FDA) will verify
through periodic (QS) inspections, the Food and Drug Administration (FDA) in regulatory through periodic (QS) inspections, the Food and Drag result in regulation may result in regulatory such assumptions. Failure to comply with in Christ concerning your device in the action. In addition, FDA may publish turne and notification submission does
Federal Register. Please note: this response to your premarket notification of the Act for Federal Register. Please note: this response to your promations of the Act for
not affect any obligation you might have moder sections. Or other Federal law not affect any obligation you might have under sections 531 through 3 12 67 and 11
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) This letter will anow you to begal finding of substantial equivalence of your device to a premarket notification. "The PDA missification 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 If you desire speoffic acries its from 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]. advertising of your do regulation entitled, "Misbranding by reference to prematiket notification" (21 CFR 807.97). Other general information on your responsibilities under the nonication (21 OF IC 0071) - 3 211-5 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 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 ol

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Cynosure SurcScan with the CO3 Er:YAG Laser

Indications For Use:

The Cynosure SureScan with the CO3 Er: YAG Laser is used for skin resurfacing, The Cynosure SureScan with the COS Et. ITTS Lace. In the Costs of bodily tissues.
and for the incision, excision, ablation or vaporization of soft bodily tissues.

Typical applications include dermatology, plastic surgery, urology, Typical applications include definatology, placio surgery, and of .
gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.

(PLEASE DO NOT WRITE BELOW TIJIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use*_*

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Ducts R992084

510(k) Number