COOLAN 300

K030810 · Coolanalgesia , Ltd. · GEX · May 5, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K030810
• Device Name: COOLAN 300
• Applicant: Coolanalgesia , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The CoolAn 300 device is intended as a skin-cooling device used to minimize pain and thermal injury during laser and light-based dermatological treatments. Alternative uses include skin cooling as a local topical anesthetic for injections.

Device Story

CoolAn 300 is a skin-cooling device designed to mitigate pain and thermal injury during dermatological laser/light-based procedures or injections. Device functions as a local topical anesthetic. Operated by clinicians in clinical settings. Device provides cooling to the skin surface to reduce thermal impact and patient discomfort during medical interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Skin-cooling device; Class II; Product Code GEX; 21 CFR 878.4810.

Indications for Use

Indicated for patients undergoing laser or light-based dermatological procedures or injections requiring local topical anesthesia to minimize pain and thermal injury.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in a simple, graphic style with bold lines.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2004

Coolanalgesia Ltd. c/o Mr. Jeff Rongero Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709

Re: K030810

Trade/Device Name: CoolAn 300 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: April 27, 2004

Dear Mr. Rongero:

Received: April 28, 2004

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of 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, de Hoos that have teen 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 gencral 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 I'DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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.

{1}------------------------------------------------

Page 2 - Mr. Jeff Rongero

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## INDICATIONS FOR USE

510(k) Number (if known): K030810

CoolAn 300 Device Name:

Indications For Use:

The CoolAn 300 device is intended as a skin-cooling device used to minimize pain and thermal injury during laser and light-based dermatological treatments. Alternative uses include skin cooling as a local topical anesthetic for injections.

Prescription Use __ X = (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number_Ka308/0