The CoolTouch Incorporated CoolTouch CT3 Nd:YAG Surgical Lasers are lasers producing emissions at 1320nm. The lasers consist of several interconnected sections: the cabinet, which houses the power supply, cooling system, microcontroller, and the laser head, the fiber optics, and the handpiece. The systems provide safety features that are designed to protect the user and patient from high voltages and laser emissions.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the CoolTouch CT3 laser systems, focusing on its substantial equivalence to a predicate device for specific indications (treatment of back acne and atrophic acne scars). It mentions compliance with certain CFR sections but does not detail performance metrics, study designs, sample sizes, or ground truth establishment.

Summary

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'AUG 21 2003

Summary of Safety and Effectiveness

KO31954

This 510(k) Summary of Safety and Effectiveness for the CoolTouch CT3 laser systems 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:	New Star Lasers, Inc. d.b.a. CoolTouch Incorporated
Address:	9085 Foothills Blvd.Roseville, CA 95747
Company Contact:	Donald V. JohnsonVice-President, Operations
Telephone:	(916) 677-1912(916) 677-1901 (FAX)
Date SummaryPrepared:	June 24, 2003
Device Name:	CoolTouch Incorporated Model CT3Laser Systems
Common Name:	Laser Instrument, Surgical Laser System and Accessories
Classification Name:	Instrument, Surgical, Powered Laser21 CFR § 878.4810Product Code: GEX
Predicate Device:	CoolTouch Incorporated "CoolTouch" and "CoolTouch II" Nd:YAGLaser Systems
Device Description:	The CoolTouch Incorporated CoolTouch CT3 Nd:YAG Surgical Lasersare lasers producing emissions at 1320nm. The lasers consist of severalinterconnected sections: the cabinet, which houses the power supply,cooling system, microcontroller, and the laser head, the fiber optics, andthe handpiece. The systems provide safety features that are designed toprotect the user and patient from high voltages and laser emissions.

Intended Use/Indications:

The CoolTouch CT3 ND:YAG Laser System is indicated for treatment of back acne and treatment of atrophic acne scars

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K031954 2 of 2

510(k) Premarket Notification CoolTouch Incorporated Model CT3 Laser Systems June 24, 2003

Performance

Standards:

The CoolTouch CT3 laser systems comply with the appropriate sections of 21 CFR §1010 and 21 CFR § 1040.

Substantial Equivalence Statement:

Based on the information in the premarket notification, CoolTouch Incorporated believes that the CoolTouch CT3 Nd:YAG laser systems are substantially equivalent to the cited legally marketed predicate device for the indications requested.

June 24, 2003

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the emblem. The emblem is composed of three curved lines that form the shape of a person.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 21 2003

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

Re: K031954

Trade/Device Name: CoolTouch Incorporated Model CT3 Laser Systems 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 24, 2003 Received: July 1, 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 (OS) 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. 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Melkerson

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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INDICATIONS FOR USE STATEMENT

510(K) Number (if known): K031954

Device Name: CoolTouch Incorporated Model CT3

Indications for Use Statement:

The CoolTouch CT3 Laser System is indicated for:

treatment of back acne 1.
1. treatment of atrophic acne scars.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Milbern

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

ೆ (k) Number -

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.