CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C

K090618 · Cynosure, Inc. · GEX · Apr 14, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090618
• Device Name: CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SmartCool family cold air device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief.

Device Story

The SmartCool family cold air device is a refrigeration unit that generates cold air; the air is delivered to the patient's skin via an air hose. It is used in clinical settings during laser and dermatological procedures. The device functions by cooling the skin surface to minimize pain and thermal injury associated with laser treatments and provides temporary topical anesthetic relief. It is operated by healthcare professionals during dermatological procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Refrigeration unit generating cold air delivered via hose. No specific materials, software, or connectivity described.

Indications for Use

Indicated for patients undergoing laser or dermatological treatments requiring pain minimization, thermal injury prevention, or temporary topical anesthetic relief.

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

• Cryo 5 (K040727)
• Cryo V6 (K060395)
• CryoMini (K080735)

Submission Summary (Full Text)

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K090618
Page 1 of 1

## APR 1:4 2009

## 510(K) Summary

| Submitter: | Cynosure, Inc.<br>5 Carlisle Road<br>Westford, MA 01886 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior Vice President of Medical Technology and Regulatory Affairs |
| Date Summary Prepared:<br>Device Trade Name: | March 6, 2009<br>Cynosure SmartCool family cold air device |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>Class II (21 CFR 878.4810) |
| Equivalent Device: | Cryo 5 (K040727), Cryo V6 (K060395), and CryoMini (K080735) |
| Device Description: | The SmartCool family cold air device consists of a refrigeration unit<br>that creates cold air. The cold air is blown onto the skin using an air<br>hose. |
| Intended Use: | The SmartCool family cold air device is intended to minimize pain and<br>thermal injury during laser and dermatological treatments and for<br>temporary topical anesthetic relief. |
| Comparison: | The SmartCool family cold air device has the same indications for use,<br>the same principle of operation, and the same performance as the<br>predicate device(s). |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The SmartCool family cold air device is a safe and effective device for<br>the 'indications for use' specified. |
| Additional Information: | none |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/15 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized depiction of an eagle. The eagle is facing to the right and has three stripes across its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -

## APR 1 4 2009

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

Re: K090618

Trade/Device Name: Cynosure SmartCool Family Cold Air Device: SmartCool, SmartCool 6, and Cryo C

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 6, 2009 Received: March 9, 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Mark M. Milkenan

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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090618
Page 1 of 1

510(k) Number (if known):

Device Name: Cynosure SmartCool Family Cold Air Device: SmartCool, SmartCool 6,

## and Cryo C.

Indications For Use:

The SmartCool family cold air device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief.

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)

Nilkeoph formx

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Ko10618 510(k) Number_