The Candela Gentlelase GL Dermatology Laser is indicated for the following uses: 1. the photocoagulation of dermatological vascular lesions. The Candela GentleLase GL Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for: 1. the reduction of pain. 2. cooling of skin prior to laser treatment.

Device Description

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 area via an optical fiber/handpiece delivery system. The Candela Gentlelase Lasers are designed with five major components: - High voltage power supply and modulator system 1. - Optical laser head 2. - Circulator system 3. - 4. Optical delivery system - Software control system 5. 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. The Candela (Modified) Gentlelase GL Laser also includes the Candela Dynamic Cooling Device integrated into the laser system. The DCD consists of 1) a source of skin refrigerant fluid, 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with the laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of refrigerant, just prior to the delivery of the laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. The intended use of the Dynamic Cooling Device is to cool the skin prior to laser treatment, to minimize thermal damage to skin during laser treatment and to reduce pain associated with laser treatment.

AI/ML Overview

The provided text describes the regulatory clearance of the Candela (Modified) GentleLase GL Laser System, which includes the Candela Dynamic Cooling Device (DCD). However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/medical device. Instead, the document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable to the information provided in this 510(k) summary.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document establishes "substantial equivalence" as the primary acceptance criterion, rather than specific performance metrics (like sensitivity, specificity, or reader improvement). The reported performance is implicitly that the device is "substantially equivalent" to its predicate devices concerning its intended use, operating principles, and key design aspects.

Given the nature of this document (a 510(k) summary for a laser system, not an AI/diagnostic device), quantitative performance metrics in the traditional sense are not explicitly stated, nor are acceptance criteria for such metrics. The "performance" is demonstrated by similarity to an already approved device.

Acceptance Criterion (Implicit)	Reported Device Performance
For Candela (Modified) Gentlelase GL Laser System:
Same intended use as predicate device (Candela Gentlelase GL laser cleared under 510(k) 972767).	The Candela Gentlelase Lasers have the same intended use: photocoagulation of dermatological vascular lesions.
Same operating principles as predicate device.	The Candela Gentlelase Lasers utilize the same operating principles (Alexandrite rod, 755nm wavelength, pulsed energy, optical fiber/handpiece delivery).
Match key design aspects (similar spot size, same wavelength, same maximum delivered power) as predicate device.	The Candela Gentlelase Lasers match key design aspects, including similar spot size, the same wavelength (755nm), and the same maximum delivered power.
For Dynamic Cooling Device (DCD) integrated into the laser system:
Same intended use as predicate DCD (Candela Dynamic Cooling Device).	The DCD has the same intended use: cooling the skin prior to laser treatment, to minimize thermal damage during laser treatment, and to reduce pain associated with laser treatment.
Same operating principles as predicate DCD.	The DCD utilizes the same operating principles (source of skin refrigerant fluid, electronically controlled solenoid delivery valve, electronic timing circuitry, connected in line with laser's triggerswitch for pulsed spray just prior to laser pulse).
Same technological and performance characteristics as predicate DCD.	The DCD has the same technological and performance characteristics.
Overall substantial equivalence to predicate devices based on assembly, operation, and uses.	"On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela (modified) Gentle Lase System is substantially equivalent to the predicate devices." (Predicate for DCD: Candela Dynamic Cooling Device; Predicate for laser: Candela Gentlelase GL laser cleared under 510(k) 972767). Component testing and functional testing of the completed laser system (including DCD) were performed.

2. Sample size used for the test set and the data provenance:

Not Applicable. This is a 510(k) summary for a laser surgical instrument, not an AI/diagnostic device. The "testing" mentioned refers to component and functional testing of the hardware, not a clinical study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. See point 2.

4. Adjudication method for the test set:

Not Applicable. See point 2.

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 for photocoagulation, not an AI-powered diagnostic tool that assists human readers.

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

Not Applicable. See point 5.

7. The type of ground truth used:

For a traditional medical device like this laser, "ground truth" typically relates to engineering specifications, safety standards, and functional performance, verified through "component testing and functional testing." It's not about diagnostic accuracy against pathology or outcomes data in the way an AI diagnostic device would be evaluated. The core "truth" being established here is that it functions as intended and is safe, similar to its predicate.

8. The sample size for the training set:

Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning.

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

Not Applicable. See point 8.

Summary

{0}------------------------------------------------

FEB 10 1998 74381

510(k) Summary

General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela (Modified) 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, Long pulse Alexandrite Laser
Predicate Device:	Candela Gentlelase GL laser cleared under 510(k) 972767.

Description:

High voltage power supply and modulator system 1.
Optical laser head 2.
Circulator system 3.
1. Optical delivery system
Software control system 5.

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.

The Candela (Modified) Gentlelase GL Laser also includes the Candela Dynamic Cooling Device integrated into the laser system. The DCD consists of 1) a source of skin refrigerant fluid, 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with the laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of refrigerant, just prior to the delivery of the laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates.

The intended use of the Dynamic Cooling Device is to cool the skin prior to laser treatment, to minimize thermal damage to skin during laser treatment and to reduce pain associated with laser treatment.

Testing:

Testing of the GentleLase Laser System, including the Dynamic Cooling Device, 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.

{1}------------------------------------------------

The Dynamic Cooling Device, which is part of the Candela GentleLase Laser System, has the same intended use, utilizes the same operating principles, and has the same technological and performance characteristics as the predicate device, the Candela Dynamic Cooling Device.

On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela On the basis of similaries in modified) Gentle Lase System is substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

FEB 1 0 1998

Re: K974381

Trade Name: Candela (Modified) GentleLase GL Dermatological Laser Regulatory Class: II Product Code: GEX Dated: November 17, 1997 Received: November 20, 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 (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

{3}------------------------------------------------

Page 2 - Mr. Caplan

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,

Ascella

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

{4}------------------------------------------------

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

Device Name: Candela (Modified) GentleLase GL Dermatology Laser

Indications For Use:

Prescription Use (Per 21 CFR 801.109)

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

the photocoagulation of dermatological vascular lesions.

The Candela GentleLase GL Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for: 1. 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)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K97438/

Prescription Use	X	OR	Over-The-Counter Use
------------------	------------------------------------------	----	----------------------

(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.