Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted on all skin types Fitzpatrick I-VI including tanned skin.

Photocoagulation and hemostasis of pigmented and vascular lesions. such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea, Venus lake, leg veins and spider veins.

Coagulation and hemostasis of soft tissue.

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. The laser is indicated for 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. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Treatment of wrinkles.

Device Description

The Candela GentleYAG Family of Laser Systems is a flashlamp-excited, Nd: YAG(Neodymium-doped Yttrium Aluminum Garnet) laser. Pulsed laser energy at a nominal wavelength of 1064 nanometers (nm) is used. This wavelength causes maximum energy absorption by the target (hair or lesion) and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target, to minimize heat transfer to surrounding tissues.

The GentleYAG 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 with aiming beam a footswitch or handswitch a remote interlock connector an optional cooling device

AI/ML Overview

This device, the Candela GentleYAG Family of Laser Systems, is cleared through the 510(k) pathway, which establishes substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through novel clinical studies. Therefore, the provided documentation does not contain a study demonstrating the device meets acceptance criteria in the traditional sense of a performance study with defined metrics.

Instead, the submission asserts substantial equivalence based on shared technological features and indications for use with previously cleared predicate devices. The "safety and effectiveness information" section in the submission primarily certifies compliance with relevant electrical safety and laser performance standards and reiterates the substantial equivalence to predicates.

Given this context, the following information is extracted and presented as relevant, even if it doesn't directly answer all aspects of your request for a study proving acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no specific performance acceptance criteria or a dedicated study in the document that measures the device's performance against these criteria for clinical efficacy. Instead, the "acceptance criteria" are implied by the features and standards shared with the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Safety:
Compliance with laser performance standards	"Candela Certifies that this device is in compliance with the laser performance standards required as per 21 CFR 1000.1040."
Compliance with electrical safety standards	"The device conforms to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2, Part 2 established by the European Community."
No new questions of safety or effectiveness raised	"We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the GentleYAG Family of Laser Systems." and "Therefore, we do not believe that introduction of the modified GentleYAG Family of Laser Systems raises any new issues of safety or effectiveness." This is a declarative statement based on comparison to predicate devices, not an empirically demonstrated performance metric from a study.
Effectiveness/Functionality:
Equivalent indications for use as predicate devices	The device "shares the same indications for use" as predicate devices. The listed indications include hair removal, photocoagulation of pigmented/vascular lesions, coagulation of soft tissue, treatment of benign pigmented lesions, and treatment of wrinkles.
Equivalent operating principles and mechanism of action as predicate devices	"shares the same operating principles, mechanism of action" as predicate devices.
Equivalent technological features (wavelength, pulse duration, etc.)	The device "shares similar functional features such as wavelength, pulse duration, pulse frequency, energy, spot sizes" with predicate devices. Specifics regarding expanded ranges are mentioned (expanded pulse durations, pulse frequencies, spot sizes, energy). The wavelength is 1064 nm.

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

Not applicable. The document does not describe a clinical performance study with a test set of data to demonstrate device performance. This is a 510(k) submission primarily relying on substantial equivalence to predicate devices, not new clinical performance data.

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

Not applicable for a 510(k) based on substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable for a 510(k) based on substantial equivalence.

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-assisted diagnostic device, and no MRMC study is mentioned.

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

Not applicable. This is a medical device (laser system), not a software algorithm, and "standalone" performance in this context is demonstrated through compliance with standards and equivalence to predicates, not a separate algorithm-only performance study.

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

Not applicable. No ground truth is established for device performance in a clinical study within this document. The "ground truth" for clearance is the regulatory determination of substantial equivalence to already cleared predicate devices, which themselves would have established their safety and effectiveness.

8. The sample size for the training set

Not applicable. This device is a laser system. No "training set" in the context of machine learning or algorithms is described.

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

Not applicable. No "training set" or ground truth for such a set is described.

Summary of the Study that "Proves" the Device Meets Acceptance Criteria (in the context of a 510(k)):

The "study" or justification for clearance is the comparison to predicate devices. The Candela GentleYAG Family of Laser Systems is deemed substantially equivalent to several predicate devices, including older versions of the Candela GentleYAG (K010104, K0022923, K022951, K023193), Lyra I (K020021, K003765, K003147), and Altus CoolGlide Family of Lasers (K023954, K010834, K003765).

The basis for this equivalence is:

Identical Indications for Use: The new device shares the same intended uses as the predicates.
Similar Operating Principles and Mechanism of Action: Both the new device and the predicates are flashlamp-excited, Nd:YAG lasers operating at 1064 nm, utilizing pulsed energy for target absorption and minimal surrounding tissue absorption.
Similar Technological Features: The submission states the device incorporates and expands upon features of the predicate devices, including expanded pulse durations, pulse frequencies, spot sizes, and energy output, while maintaining similar wavelength.
Compliance with Standards: The device certifies compliance with laser performance standards (21 CFR 1000.1040) and electrical safety standards (UL 2601 and EN 60601-1-2).

The conclusion drawn by Candela Corporation and accepted by the FDA is that because of these similarities, "no new questions of safety or effectiveness" are raised by the introduction of the modified GentleYAG Family of Laser Systems. Therefore, its "acceptance criteria" are met by demonstrating it is as safe and effective as the legally marketed predicate devices, through a comparative analysis of its design and intended use, rather than through a de novo clinical trial with discrete performance metrics.

Summary

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K033172 1 of 3

Image /page/0/Picture/1 description: The image shows the Candela company logo, which is a stylized letter C. The text "CANDELA" is printed to the right of the logo. The date "OCT 3 0 2003" is printed above the text "510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS".

This 510(k) Summary of Safety and Effectiveness for the Candela GentleYAG Family of Laser Systems 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 InformationApplicant:	Candela Corporation
Address:	530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	Lorraine Calzetta PatrovicManager, Regulatory Affairs
Date Prepared:	August , 2003
II. NamesDevice Trade Name:	GentleYAG Family of Laser Systems
Common Name	Dermatology Laser
Classification:	Class II (21 CFR § 878.4810 Laser SurgicalInstrument for use in General and PlasticSurgery and in Dermatology)

III. Predicate Devices

Candela GentleYAG a.k.a Long Pulse Nd:YAG Laser (K010104, K0022923. K022951, K023193), Lyra I (K020021,K003765, K003147) Altus CoolGlide Family of Lasers (K023954, K010834,K003765)

IV. Product Description

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K033172 2 of 3

V. Indications for Use

The GentleYAG Family of Laser Systems is intended for:

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted on all skin types Fitzpatrick I-VI including tanned skin.

Photocoagulation and hemostasis of pigmented and vascular lesions. such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea. Venus lake leg veins and spider veins

Coagulation and hemostasis of soft tissue.

Treatment of wrinkles

VI. Rationale for Substantial Equivalence

The Candela GentleYAG Family of Laser Systems shares the same indications for use, operating principles, mechanism of action, technological features as the predicate devices and therefore is substantially equivalent to the predicate devices.

VII. Safety and Effectiveness Information

The Candela GentleYAG Laser Family of Laser Systems is equivalent to the Candela GentleYAG (aka Candela Long Pulse Nd: YAG Laser) cleared under K010104, K022923,K022951,K023193 the Lyra I ( K020021,K003765, K003147) and the Altus CoolGlide Family of Lasers (K023954, K010834,K003765) in technological features, and equivalent in intended use and therefore the risks and benefits are comparable to the predicate devices. Candela Certifies that this device is in compliance with the laser performance standards required as per 21 CFR 1000.1040. The device conforms to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2, Part 2 established by the European Community. We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the Gentle Y AG Family of Laser Systems.

VIII. Conclusion

It is the opinion of Candela Corporation that the GentleYAG Family of Laser Systems is substantially equivalent to the predicate devices based on operating principles mechanism of action, and for intended use.

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K03 3172 3 of

Statement of Substantial Equivalence

The purpose of this 510(k) submission is to obtain clearance to market the Candela Gentle YAG Family of Laser Systems.

The Candela GentleYAG Family of Laser Systems presented in this submission, is a modification of the Candela GentleY AG Laser System a.k.a Candela Long Pulse Nd: YAG previously cleared under K010104, K022951, K022923, K023193.

The modifications incorporate features of the currently marketed predicate devices, including expanded pulse durations, pulse frequencies, spot sizes, energy and indications for use. The Table of Comparative Features (included as Exhibit D) shows the features of the devices, including their similarities.

As indicated in the table, the GentleYAG Famly of Laser Systems is equivalent to the currently marketed predicate devices, the Laserscope Lyra I Nd: Y AG Laser (cleared under K020021, K0037565, K 0031747), and the Altus Cool Glide Family of Lasers (cleared under K023954, K010834, K003765), based on operating principles, mechanism of action, and shares similar functional features such as wavelength, pulse duration, pulse frequency, energy, spot sizes, and indications for use. Therefore, we do not believe that introduction of the modified GentleY AG Family of Laser Systems raises any new issues of safety or effectiveness.

In conclusion, Candela believes that the Gentle YAG family of Laser Systems is substantially equivalent to the currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2003

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

Re: K033172

Trade/Device Name: Candela GentleYAG Family of 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: September 26, 2003 Received: September 30, 2003

Dear Ms. Patrovic:

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 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.

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Page 2 - Ms. Lorraine Calzetta Patrovic

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,

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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INDICATIONS FOR USE STATEMENT 033172 510(k) Number :

Candela GentleYAG Family of Laser Systems Device Name:

Indications For Use:

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted on all skin types Fitzpatrick I-VI including tanned skin.

Photocoagulation and hemostasis of pigmented and vascular lesions. such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea, Venus lake, leg veins and spider veins.

Coagulation and hemostasis of soft tissue.

Treatment of wrinkles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

iriam C. Provost

Division of General, Restorative and Neurological Devices

KO33172 510(k) Number Prescription Use Over-The-Counter Use OK (Per 21 CFR 801.109)

228

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.