COOL TOUCH 3

K031184 · New Star Lasers, Inc. · GEX · May 21, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031184
• Device Name: COOL TOUCH 3
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles.

Device Story

CoolTouch 3 is a 1320 nm Nd:YAG pulsed surgical laser system. Device comprises a cabinet housing power supply, cooling system, microcontroller, and laser source, connected to fiber optics and a handpiece. Operated by clinicians in dermatological settings for soft tissue procedures (incision, excision, ablation, vaporization) and wrinkle treatment. Microcontroller manages laser emission parameters. Output is laser energy delivered via handpiece to target tissue to achieve desired surgical effect or cosmetic improvement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nd:YAG laser system; 1320 nm wavelength; pulsed emission; includes power supply, cooling system, and microcontroller; fiber optic delivery with handpiece.

Indications for Use

Indicated for patients requiring dermatological soft tissue incision, excision, ablation, and vaporization with hemostasis, and for the treatment of fine lines and wrinkles.

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

• New Star Lasers, Inc. Model NS-130 (CoolTouch®)
• Model CoolTouch® II Nd:YAG Laser Systems

Submission Summary (Full Text)

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

031184

## Premarket Notification 510(k) Summary (As Required by 21 CFR 807.93

This 510(K) Summary of safety and effectiveness for the New Star Model CoolTouch® 3 Nd:YAG Surgical Laser system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | New Star Lasers, Inc. |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 9085 Foothills Boulevard<br>Roseville, CA 95747 |
| Contact Person: | Donald V. Johnson |
| Telephone/Fax/Email: | [phone] - Phone<br>[phone] - Fax<br>[e-mail] - Email |
| Preparation Date: | April 14, 2003 |
| Device Trade Name: | New Star Nd:YAG Surgical Laser Model CoolTouch® 3 |
| Common Name: | Nd: YAG Pulsed Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX<br>21 CFR 878-4810 |
| Legally Marketed Predicate Device: | New Star Lasers, Inc. Model NS-130 (CoolTouch®) and<br>Model CoolTouch® II Nd:YAG Laser Systems |
| Description of the New Star CoolTouch®<br>Nd:YAG Laser Systems: | The New Star CoolTouch® Nd:YAG Surgical Laser Systems<br>are ND:YAG lasers producing laser emission at 1320 nm.<br>The lasers consists of three interconnected sections: The<br>cabinet which houses the power supply, the cooling system,<br>the microcontroller and the laser, the fiber optics and the<br>handpiece. |
| Intended use of the New Star CoolTouch®<br>Nd:YAG Laser Systems: | For use in dermatology for incision, excision, ablation and<br>vaporization with hemostasis of soft tissue. For use in the<br>treatment of fine lines and wrinkles. |
| Performance Data: | None |
| Conclusion: | The New Star CoolTouch® 3 Nd:YAG Surgical Laser<br>System is substantially equivalent to the predicate devices,<br>the New Star CoolTouch® and CoolTouch® II Nd:YAG<br>laser systems. |
| Additional Information: | None requested at this time |

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

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 head with three lines extending from the back of the head, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

Mr. Donald V. Johnson Vice President of Operations New Star Lasers, Inc. 9085 Foothills Boulevard Roseville, California 95747

Re: K031184

Trade/Device Name: New Star Nd: YAG Surgical Laser Model CoolTouch® 3 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 14, 2003 Received: April 24, 2003

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 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. 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 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.

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

Page 2 - Mr. Donald V. Johnson

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

for Mark N-Millerson

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

{3}------------------------------------------------

510(k) Number

Not yet assigned

K031184

CoolTouch® 3 Device Name

For use in dermatology for incision, excision, ablation and Indications for vaporization with hemostasis of soft tissue. For use in the Use 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 Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

Mark N. Mulkerson

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

510(k) Numbe

New Star Lasers, Inc April 14, 2003

Special 510(k) Submission CoolTouch 3 Nd:YAG Laser System