COOLTOUCH, MODEL CT3S

K043046 · New Star Lasers, Inc. · GEX · Feb 1, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043046
• Device Name: COOLTOUCH, MODEL CT3S
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the CoolTouch CT3S Nd:YAG Laser System is: a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue, b) for treatment of fine lines and wrinkles, c) for treatment of back acne and atrophic acne scars, d) for treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.

Device Story

The CoolTouch CT3S is an Nd:YAG laser system emitting at 1320 nm. It comprises a cabinet housing a power supply, cooling system, and microcontroller, connected to a fiber optic and handpiece. Operated by clinicians in a medical setting, the device delivers laser energy to soft tissue for surgical or dermatological procedures. The system provides hemostasis during incision, excision, ablation, and vaporization. It is also used for cosmetic skin treatments and endovenous laser therapy for varicose veins. The clinician directs the laser output to the target tissue to achieve the desired therapeutic effect, benefiting patients by providing a minimally invasive method for tissue management and vein treatment.

Clinical Evidence

Clinical trials indicated effectiveness in treating reflux of the greater saphenous vein associated with varicose veins and varicosities. Results were referenced from previous 510(k) submissions. No new clinical performance data was generated for this specific notification.

Technological Characteristics

Nd:YAG laser system; 1320 nm wavelength; consists of cabinet (power supply, cooling system, microcontroller), fiber optic, and handpiece. Class II device.

Indications for Use

Indicated for dermatology patients requiring soft tissue incision, excision, ablation, or vaporization; treatment of fine lines, wrinkles, back acne, and atrophic acne scars; and treatment of greater saphenous vein reflux associated with varicose veins and varicosities.

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

• CoolTouch Corporation Model NS-160 (CTEV)

Submission Summary (Full Text)

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## CoolTouch Corporation Model CT3S Nd:YAG Laser System 510(k) Premarket Notification 510(k) SUMMARY

人 043046

| Submitter: | CoolTouch Corporation |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 9085 Foothills Boulevard<br>Roseville, CA 95747 |
| Contact Person: | Donald V. Johnson<br>Vice-President of Operations |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date Prepared: | |
| Device Trade Name: | CoolTouch Corporation Model CT3S Nd:YAG Laser<br>System |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Laser Surgical Instrument.<br>21 C.F.R. § 878.4810 |
| Legally Marketed Predicate Device: | CoolTouch Corporation Model NS-160, CTEV. |
| Description of the CoolTouch<br>Nd:YAG Laser Systems: | The CoolTouch Nd:YAG Laser Systems are Nd:YAG<br>lasers producing laser emission at 1320 nm. The lasers<br>consist of three interconnected sections: The cabinet,<br>which houses the power supply, cooling system,<br>microcontroller and the laser, the fiber optic, and/or the<br>handpiece. |
| Intended use of CoolTouch<br>Nd:YAG Laser Systems: | The intended use of the CoolTouch CT3S Nd:YAG<br>Laser System is:<br>a) for use in dermatology for incision, excision, ablation<br>and vaporization with hemostasis of soft tissue,<br>b) for treatment of fine lines and wrinkles,<br>c) for treatment of back acne and atrophic acne scars,<br>d) for treatment of reflux of the greater saphenous vein<br>associated with varicose veins and varicosities. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | Clinical trials also produced results that indicated that<br>the CoolTouch Nd:YAG Laser Systems are effective in<br>the treatment of reflux of the greater saphenous vein<br>associated with varicose veins and varicosities. See<br>previous related 510(k) submissions for clinical results. |
| Conclusion: | The CoolTouch CT3S Nd:YAG Laser System is<br>indicated:<br>a) for use in dermatology for incision, excision, ablation<br>and vaporization with hemostasis of soft tissue,<br>b) for the treatment of fine lines and wrinkles,<br>c) for treatment of back acne and atrophic acne scars,<br>d) for treatment of reflux of the greater saphenous vein<br>associated with varicose veins and varicosities. |
| Additional Information: | None requested at this time |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043046

Trade/Device Name: CoolTouch CT3S 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: January 21, 2005 Received: January 24, 2005

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we 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 encrease, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererors, mans of the Act include requirements for annual registration, listing of general controls profice, 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 rryour device is elassified (tools. Existing major regulations affecting your device can may be subject to suen adaterial evenlations. Title 21, Parts 800 to 898. In addition, FDA may be round in the over ments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean ITCase oc advised that I DTC issuantes syour device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must of ally it catal statutes und regalabents, including, but not limited to: registration and listing (2 h Comply with an the Hot 31equirements, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Donald V. Johnson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your and inding of substantial equivalence of your device to a legally premaince notificated 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 ir you dome 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 other golferal micronal 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,

Miriam 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

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## INDICATION FOR USE STATEMENT

510(k) Number: __ K 04304b____________________________________________________________________________________________________________________________________________________

Device Name: CoolTouch CT3S Nd:YAG Laser System

Indications for Use:

The CoolTouch CT3S Nd:YAG Laser System is indicated:

a) for use in dermatology for incision, excision, ablation and vaporization with

hemostasis of soft tissue,

b) for use in the treatment of fine lines and wrinkles,

c) for treatment of back acne and atrophic acne scars,

d) for treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Pror (Division Sign-Off) Division of General, Restorative, and Neurological Devices KO 4 38ver-the-Counter Use_ OR Prescription Use 510(k) Number 1 CFR 801.109)