the photocoagulation of dermatological vascular lesions.
the removal of hair.
The Candela GentleLase II Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for:
the reduction of pain.
cooling of skin prior to laser treatment.

Device Description

The Candela GentleLase II Laser utilizes 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 Dynamic Cooling Device functions to cool the skin prior to laser treatment, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela GentleLase II Laser is designed with six major components:

High voltage power supply and modulator system
Optical laser head
Circulator system
Optical delivery system
Software control system
Dynamic cooling device
The Candela GentleLase II Laser is 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 provided text is a 510(k) summary for the Candela GentleLase II Laser System, which is a regulatory submission to the FDA to demonstrate substantial equivalence to previously marketed devices. This document focuses on demonstrating that the new device is as safe and effective as existing ones, rather than providing a detailed study proving it meets specific acceptance criteria based on novel performance metrics.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not explicitly present in this type of regulatory submission. The document relies on equivalence to predicate devices rather than direct performance studies against new, quantified acceptance criteria for features like lesion photocoagulation or hair removal efficacy.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the document as specific performance acceptance criteria or a dedicated study showing the device meets them. The 510(k) focuses on demonstrating "substantial equivalence" to predicate devices, implying that if the predicate devices met their performance criteria, then this equivalent device would also meet them. The core "performance" reported is its functional similarity to the predicate devices.

Acceptance Criteria	Reported Device Performance
Not specified directly in this document. Substantial equivalence is the primary "acceptance".	"The Candela GentleLase II 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 devices."
Conformance to Laser Performance Standard (21 CFR 1040)	"The GentleLase II is required to conform and does conform to the Laser Performance Standard (21 CFR 1040)."
Conformance to UL 544 electrical safety standard	"In addition the device conforms to the UL 544 electrical safety standard."
Conformance to Essential Requirements of the European Union Medical Device Directives	"and the Essential Requirements of the European Union Medical Device Directives."

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

This document does not describe specific clinical performance tests with a "test set" or associated patient data. The basis for equivalence relies on the technical specifications and operational principles being similar to already cleared 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):

This information is not applicable as there is no specific "test set" and no ground truth establishment described for performance evaluation in this 510(k) summary.

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

This information is not applicable as there is no specific "test set" or adjudication process described.

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:

This is not applicable. The device is a laser system, not an AI-assisted diagnostic or therapeutic tool with human readers.

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

This is not applicable. The device is a laser system, not a standalone algorithm.

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

This information is not applicable as there is no specific performance study requiring ground truth for indications like photocoagulation or hair removal described in this 510(k) summary for the new device. The "ground truth" for the predicate devices would have been established through their initial clearance processes, likely involving clinical observations for efficacy and safety.

8. The sample size for the training set:

This information is not applicable. The device is hardware (a laser system), not a software algorithm that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

Summary of the study/evidence proving the device meets criteria (based on the document):

The "study" presented here is a demonstration of substantial equivalence to predicate devices rather than a de novo clinical trial with new performance criteria.

Methodology: The manufacturer (Candela) asserts that the GentleLase II Laser System is substantially equivalent to previously cleared predicate devices (Candela GentleLase GL, Sharplan EpiTouch Alex, Cynosure Apogee 40). This assertion is based on comparisons of:
- Intended Use: Identical (photocoagulation of dermatological vascular lesions and hair removal).
- Operating Principles: Same (Alexandrite rod, 755nm pulsed energy, optical fiber/handpiece delivery).
- Key Design Aspects: Similar (spot size, wavelength, maximum delivered power).
- Safety Conformance: The device conforms to the Laser Performance Standard (21 CFR 1040), UL 544 electrical safety standard, and EU Medical Device Directives.
Conclusion: By demonstrating that the new device is functionally and technologically equivalent to devices already on the market (and thus, presumed safe and effective), the manufacturer bypasses the need for extensive new clinical studies proving efficacy and safety. The FDA's clearance (Letter K984601) confirms this substantial equivalence.

Summary

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FEB 4 1939

510(k) Summary

General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela GentleLase II Laser System, which is substantially equivalent to previously marketed devices intended for the Photocoagulation of Dermatological vascular lesions and for the removal of hair.

Classification:	Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in Generaland Plastic Surgery and in Dermatology)
Common Name:	Dermatology Laser, Long pulse Alexandrite Laser
Predicate Devices:	Candela GentleLase GL laser cleared under 510(k)s K981351, K972767and K974381, Sharplan EpiTouch Alex Laser cleared under 510(k)K973354 and the Cynosure Apogee 40 Laser cleared under 510(k)notification number K971737

Description:

1. High voltage power supply and modulator system
1. Optical laser head
1. Circulator system
1. Optical delivery system
న్న Software control system
1. Dynamic cooling device

The Candela GentleLase II Laser is 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 laser system is for the Photocoagulation of Dermatological vascular lesions and for hair removal.

Testing:

As a laser product, the GentleLase II is required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the device conforms to the UL 544 electrical safety standard and the Essential Requirements of the European Union Medical Device Directives.

Summary of Substantial Equivalence:

The Candela GentleLase II 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 devices.

On the basis of similarities in methods of assembly, method of operation, intended uses, and clinical data Candela believes that its Candela GentleLase II Laser System is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

FEB 4 1559 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K984601

Trade Name: Candela GentleLase II Dermatology Laser Regulatory Class: II Product Code: GEX Dated: December 24, 1998 Received: December 28, 1998

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 requirement, 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 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.

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Page 2 - Mr. Jay Caplan

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 vours.

Styph Plurdic

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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510(k) Number (if known):

K984601

Device Name: Candela GentleLase II Dermatology Laser

Indications For Use:

The Candela GentleLase II Dermatology Laser is indicated for the following uses :

the photocoagulation of dermatological vascular lesions.
the removal of hair.

The Candela GentleLase II Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for:

the reduction of pain.
cooling of skin prior to laser treatment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hypt Plevels

(Division Sign-Off)

Division of General Restorative Devices <984601 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional format 1-2-96)

079

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.