The GentleYAG laser consists of the following main components: a laser system console (including software and control electronics), a control and display panel, a lens-coupled, user replacement optical fiber handpiece, a skin cooling device integrated into the handpiece, a footswitch or handswitch, a remote interlock connector.

AI/ML Overview

The Candela GentleYAG Laser System (K022951) was found substantially equivalent to predicate devices based on design aspects, indications for use, and a review of safety and effectiveness information. No specific acceptance criteria table or detailed study results demonstrating device performance against specific metrics were provided in the document.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain a table of acceptance criteria or specific reported device performance metrics. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed performance data against pre-defined acceptance criteria.

The "Safety and Effectiveness Information" section states: "The new indications for use are based on the indications for use for the predicate laser systems. Technologically, the Candela GentleYAG Laser is identical to the previous predicate Candela Long Pulse Nd: YAG Laser (K010104), and the Laserscope Lyra Surgical Laser System (K02002) therefore the risks and benefits for the GentleY AG Laser are comparable to these predicate device(s). We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the device."

This implies that the acceptance criterion for this 510(k) submission was a demonstration of substantial equivalence to the predicate devices regarding indications for use, technological characteristics, and comparable risks and benefits.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a specific clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). As explained above, the submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting new comprehensive clinical study data for the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications:

This information is not applicable as there is no description of a separate test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no description of a separate test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on substantial equivalence, not a comparative effectiveness study with human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable as the device is a laser system, not an algorithm, and its performance is not evaluated in a standalone algorithmic context.

7. The Type of Ground Truth Used:

This is not explicitly stated as there isn't a new clinical study with a defined ground truth reported for the GentleYAG Laser itself. The "ground truth" for the submission is the established safety and effectiveness of the predicate devices for their indicated uses, which the GentleYAG is claimed to be substantially equivalent to.

8. The Sample Size for the Training Set:

This information is not applicable. The GentleYAG is a physical laser system, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reasons as #8.

Summary

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ELA

I. General Information

KO22951

JAN 2 7 2003

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) Summary of Safety and Effectiveness for the Candela GentleYAG Laser System is being submitted in accordance with the requirements of the SMDA 1990, 21 CFR 807.92 and follows the guidance concerning the organization and content of a 510(k) summary.

Applicant:	Candela Corporation
Address:	530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	Lorraine NelsonManager, Regulatory Affairs
Date Prepared:	August 27, 2002
II. Names
Device Trade Name:	GentleYAG Laser System
Common Name	Dermatology Laser
Classification:	Class II (21 CFR § 878.4810 Laser Surgical Instrumentfor use in General and Plastic Surgery and inDermatology)
III. Predicate Devices
	Candela Long Pulse Nd:Yag Laser (K010104)Lyra Surgical Laser System (K020021)

IV. Product Description

The GentleY AG laser consists of the following main components:

a laser system console (including software and control electronics) ●
. a control and display panel
a lens-coupled, user replacement optical fiber handpiece ●
a skin cooling device integrated into the handpiece .
a footswitch or handswitch
. a remote interlock connector

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022951 2/2

V. Intended Use

The GentleYAG Laser is intended for use in the treatment of facial wrinkles. ●

VI. Rationale for Substantial Equivalence

The Candela GentleY AG Laser shares the same indications for use, matches key design aspects, including spot size, similar wavelength and/or the same maximum delivered power as the predicate devices, and therefore are substantially equivalent to the currently marketed Candela Long Pulse Nd: YAG Laser System (K010104) and the Laserscope Lyra Surgical Laser System (K020021).

VII. Safety and Effectiveness Information

The new indications for use are based on the indications for use for the predicate laser svstems.

Technologically, the Candela GentleYAG Laser is identical to the previous predicate Candela Long Pulse Nd: YAG Laser (K010104), and the Laserscope Lyra Surgical Laser System (K02002) therefore the risks and benefits for the GentleY AG Laser are comparable to these predicate device (s).

We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the device.

VIII. Conclusion

It is the opinion of Candela Corporation that the GentleY AG Laser System is substantially equivalent to the predicate devices based on operating principles, materials, mechanism of action, design, construction, methods of assembly and intended uses.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The logo is black and white.

Public Health Service

JAN 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Candela Corporation William H. McGrail Vice President, Research & Development & Operations 530 Boston Post Road Wayland, Massachusetts 01778

Re: K022951 Trade/Device Name: Gentle YAG Laser Syster Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic Surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: December 16, 2002 Received: December 17, 2002

Dear Mr. McGrail:

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 no: 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

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Page 2 - Mr. William H. McGrail

(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. 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). 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 yours,

Miriam C. Provost
for

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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Image /page/4/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame icon on the left and the word "CANDELA" on the right. The flame icon is black and white and has a modern, geometric design. The word "CANDELA" is written in a simple, sans-serif font.

INDICATION FOR USE STATEMENT

510(k) Number (if known): ヒロ2299

Device Name:

Candela Corporation Gentle Y AG Laser System

Indication For Use:

The Candela GentleYAG Laser System is intended for the treatment of facial wrinkles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C Provost

Vision Sign-Off ivision of General, Restorative ad Neurological Devices

K022951

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_________

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.