The Candela Gentlelase GL Lasers utilize an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Gentlelase Lasers are designed with four major components:

High voltage power supply and modulator system
Optical laser head
Circulator system
Optical delivery system
The Candela Gentlelase Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

AI/ML Overview

The Candela Gentlelase GL Laser System submission (K972767) is a 510(k) for a medical device, which seeks to demonstrate substantial equivalence to a predicate device rather than fulfilling specific, quantifiable acceptance criteria through clinical studies. Therefore, the information typically requested for AI/algorithm-driven device acceptance and studies involving ground truth and expert reviews is not directly applicable in this context.

Here's a breakdown of the information as it relates to K972767:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence: Same intended use as predicate devices.	Used for the photocoagulation of dermatological vascular lesions, identical to the predicate device.
Operating Principles Equivalence: Utilizes the same operating principles as predicate devices.	Utilizes an Alexandrite rod emitting pulsed energy at 755 nm, consistent with predicate devices.
Design Aspects Equivalence: Matches key design aspects (e.g., spot size, wavelength, max delivered power) of the predicate device.	Same wavelength (755 nm) and same maximum delivered power as the predicate device (Cynosure Photogenica LP Laser). Similar spot size to the predicate.
Safety: Equipped with safety interlock systems to protect patients and operators.	Device is equipped with safety interlock systems. (This is a design feature, not a performance metric from a clinical trial).
Functional Equivalence: Performs its intended function reliably.	Testing of the GentleLase Laser consists of component testing and functional testing of the completed Laser. (No specific performance metrics are provided in the summary, implied by successful functional testing).

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

Not applicable for this type of submission. This 510(k) submission does not describe a clinical study with a "test set" in the context of an algorithm or diagnostic device. The "testing" mentioned refers to component and functional engineering tests of the laser system itself, not performance evaluation on patient data.

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

Not applicable. There was no "test set" and no ground truth established by experts in the context of a diagnostic or AI performance study.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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

No. An MRMC study is not relevant for this type of device (a therapeutic laser) seeking substantial equivalence based on physical and functional similarities to a predicate device, rather than diagnostic accuracy or human-AI interaction.

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

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

7. The Type of Ground Truth Used

Not applicable. There was no "ground truth" used in the context of a diagnostic or AI performance study. The primary "ground truth" or basis for acceptance in a 510(k) for a therapeutic device like this is demonstrating physical and functional equivalence to a legally marketed predicate device, along with verification through engineering and functional testing.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI/algorithm-driven device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary of the Study (or Basis for Clearance):

The "study" in this context is the submission's argument for substantial equivalence to existing predicate devices.

Basis for Substantial Equivalence: Candela asserted that its Gentlelase GL Laser System is substantially equivalent to the Cynosure Photogenica LP Laser (cleared on 10/29/96 under K963094) and previously cleared Candela Q-Switched Alexandrite Lasers.
Key Arguments for Equivalence:
- Identical Intended Use: Photocoagulation of dermatological vascular lesions.
- Same Operating Principles: Both use an Alexandrite rod to emit pulsed energy at 755 nanometers.
- Similar Design Aspects: Matches key design elements like similar spot size, the same wavelength, and the same maximum delivered power as the predicate device.
- Method of Assembly and Operation: Similar to predicate devices.
Testing Performed: Component testing and functional testing of the completed laser. (Details of these tests are not provided in the summary but would have been part of the full submission).

The FDA reviewed this evidence and determined that the device was substantially equivalent, allowing it to be marketed. The acceptance criteria were implicitly met by demonstrating these similarities and functional performance through engineering tests.

Summary

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K972767

DEC - 4 1997

510(k) Summary

General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela Gentlelase GL Laser System, which is substantially equivalent to previously marketed devices intended for the photocoagulation of dermatological vascular lesions.

Classification:	Class II (21 CFR § 878.4810 Laser Surgical Instrument for use inGeneral and Plastic Surgery and in Dermatology)
Common Name:	Dermatology Laser, Longpulse Alexandrite Laser
Predicate Device:	Cynosure Photogenica LP Laser cleared on 10/29/96 under 510(k)notification number K963094

Description:

1. High voltage power supply and modulator system
1. Optical laser head
1. Circulator system
1. Optical delivery system

The Candela Gentlelase Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

The intended use of the device is for the photocoagulation of dermatological vascular lesions.

Testing:

Testing of the GentleLase Laser consists of component testing and functional testing of the completed Laser.

Summary of Substantial Equivalence:

The Candela Gentlelase Lasers have the same intended use, utilize the same operating principles and match key design aspects, including similar spotsize, the same wavelength and the same maximum delivered power as the predicate device.

On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela believes that its Candela Gentlelase lasers are substantially equivalent to previously cleared Candela Q-Switched Alexandrite Lasers and in similarity of intended use and in performance specification equivalent to the Cynosure Photogenica LP Laser.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to suggest a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jay Caplan Vice President Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778

DEC - 4 1997

Re: K972767

Trade Name: Candela GentleLase GL Dermatological Vascular Lesion Laser Regulatory Class: II Product Code: GEX Dated: October 15, 1997 Received: October 16, 1997

Dear Mr. Caplan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Caplan

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

tballa

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

Enclosure

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K972767

DEC - 4 1997

510(k) Summary

General Information:

Classification:	Class II (21 CFR § 878.4810 Laser Surgical Instrument for use inGeneral and Plastic Surgery and in Dermatology)
Common Name:	Dermatology Laser, Longpulse Alexandrite Laser
Predicate Device:	Cynosure Photogenica LP Laser cleared on 10/29/96 under 510(k)notification number K963094

Description:

1. High voltage power supply and modulator system
1. Optical laser head
1. Circulator system
1. Optical delivery system

The intended use of the device is for the photocoagulation of dermatological vascular lesions.

Testing:

Testing of the GentleLase Laser consists of component testing and functional testing of the completed Laser.

Summary of Substantial Equivalence:

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jay Caplan Vice President Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778

DEC - 4 1997

Re: K972767

Trade Name: Candela GentleLase GL Dermatological Vascular Lesion Laser Regulatory Class: II Product Code: GEX Dated: October 15, 1997 Received: October 16, 1997

Dear Mr. Caplan:

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Page 2 - Mr. Caplan

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Sincerely yours.

tballa

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

Enclosure

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K972 j10(k) Number (if known):

Device Name: Candela GentleLase GL Dermatology Vascular Lesion Laser

Indications For Use:

The Candela Gentlelase GL Dermatology Vascular Lesion Laser is used for the photocoagulation of dermatological vascular lesions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Evaluation (SDE)

Division of General Restorative Devices
510(k) Number: 272767

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional format 1-2-96)

ﺑ

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.