The CoolTouch Nd:YAG Laser Systems are indicated for use in Dermatological and Plastic Surgery applications including use in the treatment of fine lines and wrinkles.

Device Description

The CoolTouch Nd:YAG Laser Systems are ND:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optic, and the handpiece.

AI/ML Overview

The provided document is a 510(k) summary for the CoolTouch Nd:YAG Laser System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel acceptance criteria. As such, it does not contain the specific information required to complete all sections of your request.

Here's an analysis of the available information:

Acceptance Criteria and Reported Device Performance: The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it mentions that "Clinical trials produced results that indicated that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of periorbital and perioral wrinkles." This is a qualitative statement about effectiveness, not a specific performance metric. Since no explicit criteria are provided, a table cannot be constructed.
Sample size for the test set and data provenance: The document states "Clinical trials produced results...", but it does not specify the sample size for these trials, nor does it mention the country of origin or whether the data was retrospective or prospective. It refers to "previous related 510(k) submissions for clinical results," implying the data was presented elsewhere.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the summary.
Adjudication method: This information is not provided in the summary.
Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. The device is a laser system, not an AI diagnostic tool.
Standalone (algorithm only without human-in-the-loop performance) study: This is not applicable as the device is a laser system used by a clinician, not an algorithm.
Type of ground truth used: Given the indication for "treatment of fine lines and wrinkles," the ground truth likely would have involved expert assessment of wrinkle reduction (e.g., photo-grading scales, patient-reported outcomes), but this is not explicitly stated.
Sample size for the training set: This is not applicable, as the document describes a medical device, not an AI algorithm requiring a training set.
How the ground truth for the training set was established: This is not applicable.

Summary of Available Information from the Provided Text:

Criteria	Information from Document
Acceptance Criteria & Reported Device Performance	*No quantitative acceptance criteria are explicitly stated.* The document mentions: "Clinical trials produced results that indicated that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of periorbital and perioral wrinkles."
1. Sample size for test set & Data Provenance	Clinical trials were conducted, but the specific sample size is not mentioned. Data provenance (country, retrospective/prospective) is not specified. The document refers to "previous related 510(k) submissions for clinical results."
2. Number/Qualifications of Experts (Ground Truth - Test Set)	Not provided.
3. Adjudication Method	Not provided.
4. MRMC Comparative Effectiveness Study (AI vs. without AI)	Not applicable. The device is a laser system, not an AI-based diagnostic tool.
5. Standalone Performance Study (Algorithm Only)	Not applicable. The device is a laser system requiring human operation.
6. Type of Ground Truth Used	Likely involved expert assessment of wrinkle severity or reduction, possibly with patient-reported outcomes, but not explicitly stated.
7. Sample Size - Training Set (AI)	Not applicable. The document describes a medical device, not an AI algorithm.
8. Ground Truth Establishment - Training Set (AI)	Not applicable. The document describes a medical device, not an AI algorithm.

This 510(k) summary primarily serves to establish substantial equivalence with a predicate device (New Star Lasers, Inc. Model 130 Nd: YAG Surgical Laser System K962791) rather than to present detailed results of a clinical study designed to meet specific performance acceptance criteria for a novel technology. The "Nonclinical Performance Data" is stated as "None," and for "Clinical Performance Data," it refers to "previous related 510(k) submissions," indicating that the detailed clinical evidence was likely submitted and reviewed in those prior applications and not reiterated in this summary.

Summary

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ICN Phramceuticals, Inc. CoolTouch Nd:YAG Laser System Page 13

022817

ICN Pharmaceuticals, Inc. CoolTouch Nd:YAG Laser System 510(k) Premarket Notification 510(k) SUMMARY

NOV 2222002

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Submitter:	ICN Pharmaceuticals, Inc.
Address:	3300 Hyland Ave.Costa Mesa, CA 92626
Contact Person:	Edward F. Smith IIIDirector, Corporate Regulatory Affairs
Telephone:	(714) 545-0100 X 2016
Facsimile:	(714) 641-7241
Date Prepared:	August 22, 2002
Device Trade Name:	CoolTouch Nd:YAG Laser SystemCoolTouch-II Nd:YAG Laser System
Common Name:	Nd: YAG Pulsed Surgical Laser
Classification Name:	Laser Surgical Instrument.21 C.F.R. § 878.4810
Legally Marketed Predicate Device:	New Star Lasers, Inc. Model 130 Nd: YAG SurgicalLaser System (K962791).
Description of the CoolTouchNd:YAG Laser Systems:	The CoolTouch Nd:YAG Laser Systems are ND:YAGlasers producing laser emission at 1320 nm. The lasersconsist of three interconnected sections: The cabinet,which houses the power supply, cooling system,microcontroller and the laser, the fiber optic, and thehandpiece.
Intended use of CoolTouchNd: Y AG Laser Systems:	The CoolTouch Nd:YAG Laser Systems are indicatedfor use in Dermatological and Plastic Surgeryapplications including use in the treatment of fine linesand wrinkles.
Nonclinical Performance Data:	None
Clinical Performance Data:	Clinical trials produced results that indicated that theCoolTouch Nd:YAG Laser Systems are effective in thetreatment of periorbital and perioral wrinkles. Seeprevious related 510(k) submissions for clinical results.
Conclusion:	The CoolTouch Nd: YAG Laser Systems are indicated

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022817 2/2

for the general treatment of wrinkles.

Additional Information:

None requested at this time

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the serpent and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

200 Corporate Boulevaro Rockville MD 20850

ICN Pharmaceuticals, Inc. Dr. Edward F. Smith III Director, Corporate Regulatory Affairs 3300 Hyland Avenue Costa Mesa, California 92626

Re: K022817

Trade/Device Name: CoolTouch Nd: YAG and CoolTouch II Nd: YAG Laser Systems Regulation Number: 878.4810 Regulation Name: Laser surgical instrument Regulatory Class: Class II Product Code: GEX Dated: August 22, 2002 Received: August 26, 2002

Dear Dr. Smith:

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. 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 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

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Page 2 – Dr. Edward F. Smith

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

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

Enclosure

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ICN Phramceuticals, Inc. CoolTouch Nd: YAG Laser System Page 23

INDICATION FOR USE STATEME

510(k) Number: K022817

Device Name: ICN Pharmaceuticals, Inc. "CoolTouch" and "CoolTouch-II" Nd: YAG Laser Systems

Indications for Use:

The CoolTouch Nd:YAG Laser Systems are indicated for use in Dermatological and Plastic Surgery applications including use in 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 Evaluation (ODE)

uriam C. Provost

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

210(K) N Prescription Use 1 Over-the-Counter Use (per 21 CFR 801.109)

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.