COOLTOUCH VARIA ND:YAG LASER SYSTEM

K060966 · Cooltouch, Inc. · GEX · Jul 31, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060966
• Device Name: COOLTOUCH VARIA ND:YAG LASER SYSTEM
• Applicant: Cooltouch, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles.

Device Story

CoolTouch Varia is a 1064nm Nd:YAG surgical laser system. Components include a cabinet housing power supply, cooling system, microcontroller, and laser head; fiber optics; and a handpiece. Operated by clinicians in a dermatological setting. Device emits laser energy to treat fine lines and wrinkles. Safety features protect users and patients from high voltages and laser emissions. Output is controlled by the clinician to deliver therapeutic energy to the skin.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

1064nm Nd:YAG surgical laser. System includes cabinet (power supply, cooling, microcontroller, laser head), fiber optics, and handpiece. Complies with 21 CFR 1010 and 21 CFR 1040. Embedded microcontroller for system control.

Indications for Use

Indicated for dermatological treatment of fine lines and wrinkles in patients requiring such procedures.

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

• Lyra Long Pulse Nd: YAG Laser, Laserscope

Submission Summary (Full Text)

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### Summary of Safety and Effectiveness

# KO609bb

This 510(k) Summary of Safety and Effectiveness for the CoolTouch "Varia' laser system is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92 and 21 CFR § 807.93 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) Summary.

| Applicant: | CoolTouch, Inc. | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Address: | 9085 Foothills Blvd.<br>Roseville, CA 95747 - | JUL 3 1 2006 |
| Company Contact: | Donald V. Johnson<br>Vice-President of Operations | |
| Telephone: | [phone]<br>[phone] (FAX) | |
| Date Summary<br>Prepared: | March 31, 2006 | |
| Device Name: | CoolTouch, Inc. Model "Varia"<br>Nd:YAG Surgical Laser System | |
| Common Name: | Laser Instrument, Surgical Laser System and Accessories | |
| Classification Name: | Instrument, Surgical, Powered Laser<br>21 CFR § 878.4810<br>Product Code: GEX | |
| Predicate Device: | "Lyra" Long Pulse Nd: YAG Laser, Laserscope, San Jose, CA | |
| Device Description: | The CoolTouch, Inc. CoolTouch "Varia" Nd:YAG Surgical Laser is a<br>laser producing emissions at 1064nm. The lasers consist of several<br>interconnected sections: the <i>cabinet</i> , which houses the power supply,<br>cooling system, microcontroller, and the laser head, the fiber optics, and<br>the <i>handpiece</i> . The systems provide safety features that are designed<br>to protect the user and patient from high voltages and laser emissions. | |

#### Intended Use/Indications:

The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles.

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#### Performance Standards:

The CoolTouch "Varia" laser system complies with the appropriate sections of 21 CFR §1010 and 21 CFR § 1040.

# Substantial Equivalence

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#### Statement:

Based on the information in the premarket notification, the CoolTouch, Inc. believes that the "Varia" Nd:YAG laser system is substantially equivalent to the cited legally marketed predicate device for the indications requested.

## April 6, 2006 ·

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 3 1 2006

CoolTouch, Inc. % Mr. Donald V. Johnson Vice President of Operations 9085 Foothills Boulevard Roseville, California 95747

Re: K060966

Trade/Device Name: CoolTouch Varia Nd: YAG Laser System 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: June 29, 2006 Received: June 30. 2006

Dear Mr. Johnson:

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 Mav 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. Iisting 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

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Page 2 - Mr. Donald V. Johnson

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. 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/cdrl/industry/support/index.html.

Sincerely yours,

Helene Semenius

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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#### INDICATIONS FOR USE STATEMENT

# 510(K) Number (if known): _ K 0 6 09 b b

Device Name: CoolTouch Varia Nd:YAG Laser System

Indications for Use Statement:

The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles.

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

Concurrence of CDRH, Office of Device Eyatuation (ODE)

Hubert Turner

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

OR Over-the-Counter Use
510(k) Number K666966

Prescription Use (Per 21 CFR 801.109)