The Candela GentleLASE Family of Lasers 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 target area via optical fiber/handpiece delivery system. The Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces a circular beam on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece. The GentleLASE Family of Laser Systems 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 Family of Laser Systems 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 provided text describes the Candela GentleLASE Family of Laser Systems, its intended use for the treatment of wrinkles, and its substantial equivalence to a predicate device. However, it does not include detailed information about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria, particularly in the context of clinical effectiveness for wrinkle treatment.

Here's an breakdown based on the information provided and what is missing:

The submission mainly focuses on regulatory compliance (Laser Performance Standard 21 CFR 1040, UL 2601, EN 60601-1-2) and establishing substantial equivalence to a predicate device (Candela GentleLASE GL, K994260). Substantial equivalence means it has the same intended use, similar operating principles, and matches key design aspects (spot size, wavelength, maximum delivered fluence) as a previously cleared device.

The claim for the treatment of wrinkles is stated to be "based on a controlled clinical study using a device that has been cleared for use in the market." This implies the predicate device (Candela GentleLASE GL) was proven effective for wrinkle treatment, and because the new device is substantially equivalent, it also claims this indication.

Missing Information:

The document explicitly states that the indications for use for wrinkle treatment are based on a controlled clinical study using a device that has been cleared for use in the market. This implies the predicate device (Candela GentleLASE GL, K994260) had such a study, and the new device is inheriting that claim due to substantial equivalence.

Therefore, the detailed information requested in the prompt's points 1-9 regarding the new device's performance acceptance criteria and a study proving it meets them is largely not present in the provided text. The submission focuses on substantial equivalence rather than a new standalone clinical efficacy study.

However, based on the information available and making inferences where necessary for the context of a 510(k) submission based on substantial equivalence:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance (Inferred from Substantial Equivalence Basis)
Same intended use: Treatment of wrinkles	Meets: Intended for the treatment of wrinkles
Similar operating principles	Meets: Utilizes an Alexandrite rod, emits pulsed energy at 755nm, optical fiber/handpiece delivery, Dynamic Cooling Device
Similar spot size	Meets: Matches predicate device's spot size
Same wavelength	Meets: 755 nanometers, same as predicate device
Same maximum delivered fluence	Meets: Matches predicate device's maximum delivered fluence
Conformance to Laser Performance Standard (21 CFR 1040)	Meets: Conforms to 21 CFR 1040
Conformance to UL 2601 Electrical Safety Standard	Meets: Conforms to UL 2601
Conformance to EN 60601-1-2 (Harmonized Standard)	Meets: Conforms to EN 60601-1-2

Please note: These "acceptance criteria" and "reported device performance" are inferred based on the claims of substantial equivalence and safety/regulatory compliance. The document does not provide specific numerical performance metrics for wrinkle reduction, nor does it define specific clinical acceptance criteria for effectiveness (e.g., "X% reduction in wrinkle severity in Y% of patients"). The effectiveness for wrinkle treatment is, by extension, claimed from the predicate device.

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

Not explicitly provided for the new device. The document states: "The indications for use for the treatment of wrinkles is based on a controlled clinical study using a device that has been cleared for use in the market." This refers to the predicate device (Candela GentleLASE GL, K994260). The details of that study are not included in this 510(k) summary.

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)

Not explicitly provided for the new device or the underlying predicate device study.

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

Not explicitly provided for the new device or the underlying predicate device study.

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 medical treatment, not an AI-assisted diagnostic or interpretative system that would involve "human readers" in the context of MRMC studies for AI.

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

Not applicable. This pertains to an algorithm's performance, while the device is a physical laser system. The "standalone" performance here would refer to the laser's physical parameters (wavelength, fluence, spot size), which are mentioned as consistent with the predicate device. The clinical effectiveness for wrinkle treatment is derived from the predicate device's study.

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

Not explicitly provided. Given the indication of wrinkle treatment, the ground truth for effectiveness in the predicate device's study would likely involve clinical outcomes data (e.g., blinded physician assessment of wrinkles severity, patient satisfaction, photographic analysis).

8. The sample size for the training set

Not applicable. This refers to machine learning models, not a physical medical device submission based on substantial equivalence.

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

Not applicable. This refers to machine learning models.

Summary

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

$$
\varkappa \circ \mathfrak{Z} \star \mathfrak{Z} \circ \mathfrak{Z} \qquad \forall \nu
$$

MAR 1 2 2003

General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela GentleLASE Family of Laser Systems, which is substantially equivalent to previously marketed devices . The GentleLASE Family of lasers is indicated for use for the treatment of wrinkles.

Submitted by:	Candela Corporation530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	William H. McGrail
Date prepared:	December 26, 2002
Classification:	Class II (21 CFR § 878.4810 Laser Surgical Instrument for use inGeneral and Plastic Surgery and in Dermatology)
Common Name:	Dermatology Laser, GentleLASE Family of Laser Systems
Predicate Devices:	Candela GentleLASE GL (K994260)

Description:

High voltage power supply and modulator system 1.
1. Optical laser head
Circulator system 3.
1. Optical delivery system
Software control system న్.
1. Dynamic cooling device

The Candela GentleLASE Family of Laser Systems 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.

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

GentleLASE Family of Laser Systems 510k Summary

KO24335 24

Testing:

As laser products, the GentleLASE Family of laser Systems are required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the GentleLASE Family of Laser Systems conforms to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2, Part 2 established by and required by the European Community.

Safety and Effectiveness Information:

The indications for use for the treatment of wrinkles is based on a controlled clinical study using a device that has been cleared for use in the market. We therefore believe that there are no questions of safety or effectiveness raised by the introduction of the Candela GentleLASE Family of Laser Systems.

Summary of Substantial Equivalence:

The Candela GentleLASE Family of Laser Systems have the same intended use, utilizes similar operating principles and matches key design aspects, including similar spot size, the same wavelength and the same maximum delivered fluence as the predicate device.

On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela Corporation believes that the Candela GentleLASE Family of Laser Systems is substantially equivalent to the predicate device.

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUM." is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2003

Mr. William H. McGrail Vice President Research & Development and Operations Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778

Re: K024335

Trade/Device Name: GentleLASE 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: December 26, 2002 Received: December 27, 2002

Dear Mr. McGrail:

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.

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

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. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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

ful 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

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

Image /page/4/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is black on the left side and has horizontal lines on the right side. The word "CANDELA" is in a simple, sans-serif font.

INDICATION FOR USE STATEMENT

K024331 510(k) Number (if known):

Candela GentleLASE Family of Laser Systems Device Names

Indications For Use:

1. Treatment of Wrinkles
  (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109) Division of General, Restorative and Neurologica: Devices 1842-1 4024335 510(k) Number

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.