The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions (1064 and 532 nm wavelengths), the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and the dermatological use for the non invasive treatment of facial wrinkles (1064 nm wavelength).

Device Description

The DEPILASE TWIN YAG 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, with the option of frequency doubling the fundamental laser wavelength, from 1064 nm to 532 nm. The frequency doubling wavelength is obtained by passing with the laser radiation through a special crystal called Second Harmonic Crystal (SHC). 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 TWIN YAG 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 TWIN YAG Laser System. It focuses on demonstrating substantial equivalence to a predicate device rather than describing a performance study with specific acceptance criteria and detailed results.

Therefore, most of the information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided document.

Here's a breakdown of what can and cannot be extracted:

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

Not present. The document does not specify quantitative acceptance criteria for device performance or report specific performance metrics from a study. It asserts "The DEPILASE TWIN YAG Laser System output characteristics are very similar to those of the predicate device" but provides no data.

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

Not present. No test set or clinical study data is described. The submission relies on substantial equivalence to a previously cleared device.

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 present. No ground truth establishment for a test set is described.

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

Not present. No adjudication method is described because no test set or clinical study is detailed.

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 dermatological applications, not an AI-based diagnostic tool that would typically involve human readers or MRMC studies. No such study is mentioned.

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

Not applicable. This is a laser device, not an algorithm. Standalone performance is not relevant in the context of this device type as it's not an AI/software-as-a-medical-device.

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

Not present. No ground truth is described because no clinical performance study is detailed.

8. The sample size for the training set

Not applicable/Present (indirectly). This device is a physical laser system, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for this device would refer to its design, engineering, and manufacturing process based on established laser technology. The comparison focuses on the predicate device, the Laserscope Lyra (K020021), which serves as the benchmark for equivalence.

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

Not applicable. As above, no training set for an AI algorithm is involved.

Summary of Device and Equivalence Claim (from the document):

The DEPILASE TWIN YAG Laser System is an Nd:YAG laser system for dermatological applications.

Intended Use: Non-invasive treatment of facial wrinkles (1064 nm laser emission). Other indications mentioned in Appendix F include: coagulation and haemostasis of vascular lesions (1064 and 532 nm wavelengths), and removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI.

Substantial Equivalence Claim: The device is claimed to be substantially equivalent to the Laserscope Lyra (K020021) Nd:YAG laser for the non-invasive treatment of facial wrinkles.

Basis for Equivalence:

Identical intended use for facial wrinkles.
Technologically identical characteristics: flashlamp pumped Nd:YAG laser rod generating 1064 nm light, delivered via optical fiber and focusing handpiece.
"Very similar" output characteristics to the predicate device.
Both are microprocessor-controlled.
Both use Class I aiming beams.
Both use internal closed-loop water-air heat exchange for thermal control.
Risk and benefits are comparable to the predicate device for similar applications.

The document does not detail a study conducted with the DEPILASE TWIN YAG Laser System to prove it meets specific acceptance criteria. Instead, it argues that its device is equivalent to a legally marketed predicate device, relying on the predicate's prior clearance and established safety and effectiveness.

Summary

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MAY 1 4 2003

K0 30510

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Appendix E

510 (k) Summary

1. General Information:

Company:	Depilase Group LtdOne Canada SquareCanary WharfLondon E14 5DYUnited Kingdom
Contact Person:	Dr. Mario Luca Russo
Preparation:	11-15-02
Device Trade Name:	DEPILASE TWIN YAG Laser System
Common Name:	Long Pulsed Nd:YAG Surgical, Powered, Lase79-GEX21 CFR 878-48

I. Description

The DEPILASE TWIN YAG 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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II. Intended Use

The DEPILASE TWIN YAG Laser System is indicated for the use in dermatological applications for the non invasive treatment of facial wrinkles ( 1064 nm laser emission).

III. Summary of Substantial Equivalence

Depilase believes that its DEPILASE TWIN YAG Laser System is substantially equivalent. regarding the 1064 nm laser emission , to the Laserscope Lyra (K020021) Nd: YAG laser. previously cleared for the use in dermatological applications for the non invasive treatment of facial wrinkles.

It therefore has the same Intended Use as the DEPILASE TWIN YAG Laser System.

Technologically, the predicate device has identical characteristics to the DEPILASE TWIN Y AG Laser System, comprising a flashlamp pumped Nd: Y AG laser rod generating light at a wavelength of 1064 nm, which is subsequently delivered to the patient via an optical fibre delivery system and focusing handpiece.

The DEPILASE TWIN YAG Laser System output characteristics are very similar to those of the predicate device.

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 TWIN YAG Laser System are comparable to the predicate device 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 is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized image of an eagle with three lines representing its wings and body. The eagle faces to the right.

MAY 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Mario Luca Russo Director of Research and Development Depilase Group Ltd. One Canada Square Canary Wharf London E14 5DY United Kingdom

Re: K030510

Trade/Device Name: DEPILASE TWIN YAG Laser System 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: January 5, 2003 Received: February 19, 2003

Dear Dr. Russo:

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 - Dr. Mario Luca Russo

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

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

K030510 510 (K) Number (if known): _

Device Name:

DEPILASE TWIN YAG 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) (Division Sign-Off) Division of General, Restorative and Neurological Devices KO30510 510(k) Number Prescription Use OR Over The Counter Use (per 21 CFR 801.109)

Premarket Notification for DEPILASE TWIN YAG Laser System

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.