The Candela (Modified) GentleLase GL 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 Lasers are 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 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

Here's an analysis of the provided text regarding the Candela GentleLase GL Laser System's acceptance criteria and supporting study information:

It's important to note that the provided document is a 510(k) summary for premarket notification, not a full clinical study report. Therefore, specific details about acceptance criteria, detailed performance metrics, and in-depth study methodology are often summarized or not present in the same way they would be in a peer-reviewed publication or a comprehensive clinical report.

Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with corresponding reported performance metrics. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to predicate devices. The primary 'performance' described is the ability to achieve the intended uses without unexpected safety issues, aligning with the predicate device's performance.

Acceptance Criterion (Implied)	Reported Device Performance
Substantially equivalent in safety to predicate devices	A clinical trial demonstrated the device "removes unwanted hair without raising any unexpected safety issues."
Substantially equivalent in effectiveness for indicated uses	The device has the same intended use as predicate devices: Photocoagulation of Dermatological vascular lesions and hair removal.
Similar operating principles to predicate devices	Utilizes an Alexandrite rod, emits pulsed energy at 755 nm, near infrared region, optical fiber/handpiece delivery, Dynamic Cooling Device. These are stated to be "the same operating principles" as predicate devices.
Similar key design aspects to predicate devices	Similar spot size, same wavelength, same maximum delivered power as predicate devices.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. The document simply states "A clinical trial demonstrated that the GentleLase Laser System removes unwanted hair..." without providing the number of participants or treatments.
- Data Provenance: Not specified.
- Retrospective/Prospective: Not specified, but likely prospective given it's a "clinical trial" to demonstrate safety and effectiveness for marketing approval.
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 specified. The document does not describe how the success or failure of hair removal or lesion photocoagulation was explicitly measured or by whom.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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:
- No, an MRMC study was not done. This device is a laser system for dermatological treatment and hair removal, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in essence. The clinical trial likely evaluated the performance of the device itself (the laser system) in standalone operation, applied by a human operator, to achieve its intended effect (hair removal, lesion photocoagulation). There is no "algorithm" in the sense of a standalone AI system being evaluated here without human involvement. The device is the therapeutic and cosmetic tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state the "ground truth" method. For hair removal, ground truth would typically involve assessing the reduction in hair count or density over time, often through visual inspection, photography, or specific measurement techniques. For photocoagulation of vascular lesions, ground truth would relate to the reduction or clearance of the lesion, assessed clinically. It would fall under outcomes data or clinical assessment.
The sample size for the training set:
- Not applicable. This device is a physical laser system, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.
How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of device.

Summary

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981j3)7

JUL 13 1998

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 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) 974381, CynosurePhotogenica LP Laser cleared under 510(k) notification numbers K963094and K971737 and the Sharplan Model 5000 Laser cleared under 510(k)number 971784

Description:

1. High voltage power supply and modulator system
Optical laser head 2.
1. Circulator system
Optical delivery system 4.
న్న Software control system
1. Dynamic cooling device

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 laser system is for the Photocoagulation of Dermatological vascular lesions and for hair removal.

Testing:

A clinical trial demonstrated that the GentleLase Laser System removes unwanted hair without raising any unexpected safety issues.

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 devices.

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

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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, composed of three overlapping profiles facing to the right. The profiles are rendered in black and have a flowing, wave-like quality. 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

JUL 1 3 1998

Mr. Jay Caplan ·Vice President Candela Laser Corporation 530 Boston Post Road Wayland. Massachusetts 01778-1886

Re: K981351 Trade Name: Candela GentleLase GL Dermatological Laser Regulatory Class: II Product Code: GEX Dated: April 13, 1998 Received: April 14, 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 (OS) 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.

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.

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Page 2 - Mr. Jay Caplan

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,

Callie M. Witte, PhD, MD

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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g81351

510(k) Number (if known):

Device Name: __Candela (Modified) GentleLase GL Dermatology Laser

Indications For Use:

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

the Photocoagulation of Dermatological vascular 1. lesions.
the removal of hair. 2.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K981351

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
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(Optional format 1-2-96)(

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.