Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue black tattoos) and plaques.
Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Removal of unwanted hair in skin types I to VI
Photocoagulation and hemostasis of pigmented and vascular lesions
Coagulation and hemostasis of soft tissue.

Device Description

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

This is a 510(k) summary for a medical device (Candela GentleYAG Laser System), which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria through a study with performance metrics. Therefore, many of the requested elements for a study describing acceptance criteria and device performance are not present in this document.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, or a specific treatment outcome percentage) for the GentleYAG Laser System. Its rationale for clearance is based on substantial equivalence to existing predicate devices, not on meeting new quantitative performance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

No new clinical study data or test set information is provided for the GentleYAG Laser System demonstrating its performance against specific acceptance criteria. The submission relies on the established safety and effectiveness of its predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as no new clinical study data or test set requiring ground truth establishment is presented for the GentleYAG Laser System in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no new clinical study data or test set requiring adjudication is presented for the GentleYAG Laser System in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser system, not an AI software/diagnostic tool, so MRMC studies and AI assistance metrics are irrelevant.

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

Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no new clinical study data requiring ground truth is presented for the GentleYAG Laser System in this document. The "ground truth" for its equivalence argument comes from the established safety and effectiveness of its predicate devices through their prior clearances and market use.

8. The sample size for the training set

Not applicable. This document is for a medical device (laser system), not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set is relevant to this device submission.

Summary based on the provided text:

The core of this 510(k) submission is to demonstrate substantial equivalence to currently legally marketed predicate devices, not to present new clinical study data proving the GentleYAG Laser System meets specific, newly defined quantitative performance acceptance criteria.

The document explicitly states:

VI. Rationale for Substantial Equivalence: "The Candela GentleYag 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 Altus Family of Cool Glide Lasers (K014040)."
VII. Safety and Effectiveness Information: "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), therefore the risks and benefits for the GentleYAG Laser are comparable to this predicate device. We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the device."

Therefore, the "study that proves the device meets the acceptance criteria" is implicitly the prior regulatory review and market performance of the predicate devices. The "acceptance criteria" are effectively the established safety and effectiveness profiles and engineering specifications of those predicate devices, which the GentleYAG Laser System is declared to match.

Summary

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KO22923

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.

I. General Information

Applicant:	Candela Corporation
Address:	530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	Lorraine NelsonManager, Regulatory Affairs
Date Prepared:	August 22, 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)Altus Family of Cool Glide Lasers (K014040)

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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V. Intended Use

The GentleY AG Laser is intended for use in the treatment of :

. Benigm pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue black tattoos) and plaques.
Pigmented lesions to reduce lesion size, for patients with lesions that would . potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where . vascularity is an integral part of the scar.
Removal of unwanted hair in skin types I to VI .
Photocoagulation and hemostasis of pigmented and vascular lesions .
. Coagulation and hemostasis of soft tissue.

VI. Rationale for Substantial Equivalence

The Candela GentleYag 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 Altus Family of Cool Glide Lasers (K014040).

VII. Safety and Effectiveness Information

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), therefore the risks and benefits for the GentleYAG Laser are comparable to this predicate device.

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

VIII. Conclusion

Candela believes that the GentleYAG 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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2003

Candela Corporation Lorraine Nelson Manager. Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778-1886

Re: K022923

Trade/Device Name: Gentle YAG Laser System 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: September 3, 2002 Received: September 4, 2002

Dear Ms. Nelson:

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 -- Ms. Lorraine Nelson

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 yours,

Miriam C. Provost
for
Celia M. Witten, Ph.D., MD

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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INDICATION FOR USE STATEMENT

K-022923 510(k) Number (if known):

Device Name:

Candela Corporation GentleY AG Laser System

Indications For Use:

The Candela GentleYAG Laser is intended for use for:

Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar . lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue black tattoos) and plaques.
Pigmented lesions to reduce lesion size, for patients with lesions that would . potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is . an integral part of the scar.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

Prescription Use(Per 21 CFR 801.109)	X
------------------------------------------	-----------------------------------------

510(k) Number	K022423
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.