AFFIRM CO2 AND AFFIRM CO2 HP

K081424 · Cynosure, Inc. · GEX · Mar 19, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K081424
• Device Name: AFFIRM CO2 AND AFFIRM CO2 HP
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Affirm CO2 and Affirm CO2 HP lasers with SmartScan scanner are indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental, and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Device Story

Affirm CO2 and Affirm CO2 HP are CO2 gas laser systems (10.6 µm wavelength) used for soft tissue surgery. The device is activated via foot switch. It is intended for use by clinicians in various surgical specialties including dermatology, plastic surgery, ENT, and gynecology. The laser energy is applied to tissue to perform incision, excision, ablation, vaporization, or coagulation. When used with the SmartScan scanner, the device performs ablative skin resurfacing. The system is a floor-standing unit weighing 25 kg.

Clinical Evidence

No clinical data.

Technological Characteristics

CO2 gas laser system; 10.6 µm wavelength; 110 VAC, 15A, 50-60 Hz power requirement; 25 kg weight; 180x62x42 cm dimensions; foot switch activation; includes optional SmartScan scanner for ablative skin resurfacing.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissue in patients requiring surgical intervention in dermatology, plastic surgery, ENT, gynecology, neurosurgery, dental, oral, and genitourinary specialties. Also indicated for ablative skin resurfacing.

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

• Smart CO2 laser
• SmartXide CO2 with DOT Scanner laser

Submission Summary (Full Text)

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## 510(K) Summary

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K,081424

| Submitter: | Cynosure, Inc.<br>5 Carlisle Road<br>Westford, MA 01886 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | May 16, 2008 |
| Device Trade Name: | Affirm CO2 and Affirm CO2 HP lasers |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.4810 |
| Equivalent Device: | Smart CO2 laser and SmartXide CO2 with DOT Scanner laser |
| Device Description: | Affirm CO2 and Affirm CO2 HP lasers are CO2 laser, having CO2 gas<br>as the lasing medium. It is a laser with a wavelength of 10.6 µm.<br>Laser activation is by foot switch. Overall weight of the laser is 25<br>Kg, and the size is 180x62x42 cm (HxWxD).<br>Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | Affirm CO2 and Affirm CO2 HP lasers are indicated for incision,<br>excision, and coagulation of body soft tissue. |
| Comparison: | The Affirm CO2 and Affirm CO2 HP lasers are substantially equivalent<br>to the Smart CO2 laser and the SmartXide CO2 with DOT Scanner<br>laser, with the same principle of operation, the same wavelength and<br>essentially the same power range as the predicate devices for the same<br>indications for uses. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Affirm CO2 and Affirm CO2 HP lasers are another safe and<br>effective device for body soft tissue applications. |
| Additional Information: | none |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cynosure, Inc. % Mr. George Cho Senior Vice President of Medical Technology 5 Carlisle Road Westford, Massachusetts 01886

MAR 1 9 2009

Re: K081424

Trade/Device Name: Affirm CO2 and Affirm CO2 HP lassers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II

Product Code: GEX Dated: March 13, 2009 Received: March 16, 2009

#### 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 indiver of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device on regally
to proceed to the market to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveyes arverse arverse at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,
Mark M Millam

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 1 08 | 424

Device Name: Affirm CO2 and Affirm CO2 HP lasers

Indications For Use:

The Affirm CO2 and Affirm CO2 HP lasers with SmartScan scanner are indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental, and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

> Prescriptive Use X OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mitchel forman

Division of General, Restorative, and Neurological Devices

**510(k) Number** K081424