The DEPILASE YAG LASE PLUS Laser System is intended for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types.

Device Description

The DEPILASE YAG LASE PLUS Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.

The DEPILASE YAG LASE PLUS Laser System is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

AI/ML Overview

The provided text is a 510(k) Summary for the DEPILASE YAG LASE PLUS Laser System. This document focuses on establishing substantial equivalence to previously cleared devices rather than on presenting results from clinical trials with specific acceptance criteria and performance data in the format requested.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be fulfilled from the provided text. The document describes the device, its intended use, and argues for its substantial equivalence to predicate devices (Laserscope Lyra K990718 and Altus Medical Aesthetic CoolGlide K991798). It does not contain information about new studies conducted to prove the performance of the DEPILASE YAG LASE PLUS Laser System against specific acceptance criteria.

Here's an attempt to address the request based only on the provided information, noting where information is absent:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criteria	Reported Device Performance
Clinical Performance	Not explicitly stated as specific quantifiable metrics (e.g., success rate, safety endpoints) for this device. The document implies that performance is comparable to predicate devices.	Not explicitly reported for this device in the provided text. The document states that "The risk and benefits of the DEPILASE YAG LASE PLUS Laser System are comparable to the predicate devices when used for similar clinical applications." This implies historical performance of predicate devices is acceptable.
Technical Performance	Not explicitly stated as quantifiable metrics. The document implies technical equivalence to predicate devices.	The device ("DEPILASE YAG LASE PLUS Laser System output characteristics are very similar to those of predicate devices"). The device is described as having "identical characteristics" (flashlamp pumped Nd:YAG, 1064nm, optical fiber delivery, focusing handpiece) to predicate devices.
Safety	Not explicitly stated as quantifiable objectives. Implied: no new safety concerns compared to predicate devices.	"It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device." The device uses Class I aiming beams, which "pose no hazard to the user," similar to predicate devices.

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

Sample Size: Not applicable/not provided. The submission is based on substantial equivalence to predicate devices, not on a new clinical study with a test set of patients.
Data Provenance: Not applicable/not provided for a new clinical study. The "data" referenced relates to the established safety and effectiveness of the predicate devices.

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

Number of Experts: Not applicable/not provided. No new test set data requiring expert-established ground truth is presented in this 510(k) summary.
Qualifications of Experts: Not applicable/not provided.

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

Adjudication Method: Not applicable/not provided.

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

MRMC Study: No. This device is a laser system, not an AI-assisted diagnostic or imaging device used by human readers in the context of an MRMC study.

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

Standalone Study: Not applicable. This is a medical device (laser system), not an algorithm.

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

Type of Ground Truth: Not applicable for this device's submission in the provided text. The submission relies on the established safety and effectiveness track record (implied outcomes data, clinical experience, and regulatory clearance) of the predicate devices.

8. The sample size for the training set

Sample Size: Not applicable/not provided. This document does not describe the development or training of an algorithm.

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

Ground Truth Establishment: Not applicable/not provided.

Summary of what the document does provide regarding its "proof":

The "study" in this context is a substantial equivalence argument to predicate devices cleared by the FDA. The proof is based on demonstrating:

Identical Intended Use: The DEPILASE YAG LASE PLUS Laser System has the same indications for use as the predicate devices (coagulation and haemostasis of vascular lesions, and permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including suntanned skin).
Similar Technological Characteristics: All utilize flashlamp pumped Nd:YAG laser rods, generating light at 1064nm, delivered via optical fiber and focusing handpiece, microprocessor controlled, use Class I aiming beams, and internal closed-loop water-air heat exchange for cooling.
Comparable Performance (Implied): The output characteristics are "very similar" to predicate devices, and risks and benefits are comparable.

Therefore, the "proof" is a regulatory argument for equivalence rather than a detailed report of a new clinical investigation with quantifiable acceptance criteria.

Summary

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K 20 16 7

Appendix E

510 (k) Summary

FEB 2 7 2002

General Information: 1.
・・

Company:	Depilase Group LtdOne Canada SquareCanary WharfLondon E14 5DYUnited Kingdom
Contact Person:	Dr. Mario Luca Russo
Preparation:	12-01-01
Device Trade Name:	DEPILASE YAG LASER PLUS Laser System
Common Name:	Long Pulsed Nd:YAG Surgical, Powered, Laser79-GEX21 CFR 878-48

I. Description

The DEPILASE YAG LASE PLUS Laser System is designed with 5 major sub-systems:

a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

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The DEPILASE YAG LASE PLUS Laser System is indicated for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I – VI, including suntanned skin types.

III. Summary of Substantial Equivalence

Depilase believes that its DEPILASE YAG LASE PLUS Laser System is substantially equivalent to the Laserscope Lyra (K990718), and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG lasers, previously cleared for both the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I – VI, including suntanned skin types.

They therefore have the same Intended Use as the DEPILASE YAG LASE PLUS Laser System.

Technologically, the predicate devices have identical characteristics to the DEPILASE YAG LASE PLUS Laser System, all comprising a flashlamp pumped Nd: YAG laser rod generating light at a wavelength of 1064nm, which is subsequently delivered to the patient via an optical fibre delivery system and focusing handpiece.

The DEPILASE YAG LASE PLUS Laser System output characteristics are very similar to those of predicate devices.

All lasers are microprocessor controlled devices.

All lasers utilize Class I aiming beams which pose no hazard to the user.

All systems utilize an internal closed loop water-air heat exchange circuit for optimal thermal control of the laser cavity.

The risk and benefits of the DEPILASE Y AG LASE PLUS Laser System are comparable to the predicate devices when used for similar clinical applications.

It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or eagle in flight, rendered in black lines. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2002

Depilase Group Ltd. c/o Ms. Pamela Gwynn Engineering Team Leader Underwriters Laboratories, Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, North Carolina 27709

Re: K020463

Trade/Device Name: DEPILASE YAG LASE PLUS Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 3, 2002 Received: February 12, 2002

Dear Ms. Gwynn:

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.

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Page 2 – Ms. Pamela Gwynn

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to ough maing of substantial equivalence of your device to a legally premails in the motions of the 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 If you desire specific advice for you in vitro diagnostic devices), please contact the Office of additionally 21 Of IC For 8659. Additionally, for questions on the promotion and advertising of Comphance at (301) 591-1637. Heater Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation chitities, "Nilocraning of esponsibilities under the Act may be obtained from the Oincl general information of your mational 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,

R. Mark N. Millman

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

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APPENDIX F

INDICATIONS FOR USE STATEMENT

K020463 510 (K) Number (if known):

Device Name:

DEPILASE YAG LASE PLUS LASER SYSTEM

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number K020463

Prescription Use
(per 21 CFR 801.109)
OR Over The Counter Use

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.