The DEPILASE TWIN LASE 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.

Device Description

The DEPILASE TWIN LASE Laser System is based on Nd: YAG and Alexandrite laser technology. Within the system, one optical cavity contains the Nd: YAG crystal, and another optical cavity contains the Alexandrite crystal, which are activated by means of the use of a flashlamp. After each 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 individual optical fibre delivery system to a focusing handpiece. The laser is used in a noncontact mode.

The DEPILASE TWIN LASE Laser System is designed with 6 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 2 Hz.
d) An Alexandrite laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
e) Two optical delivery systems, interfacing the energy from each laser cavity to the patient via an indipendent optical fibre and focusing handpiece.
f) 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 LASE Laser System. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a de novo study with specific acceptance criteria and performance metrics for a completely new device.

Therefore, the requested information regarding acceptance criteria, device performance, study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not available in the provided text.

The core of this 510(k) submission is to show that the DEPILASE TWIN LASE Laser System has the same intended use and similar technological characteristics to predicate devices. The document directly states: "The risk and benefits of the DEPILASE TWIN LASE 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."

To address the prompt as much as possible, here's what can be inferred or stated from the text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The implied acceptance criteria for this 510(k) is "substantial equivalence" to previously cleared predicate devices for the stated intended uses. This means the device should possess similar technological characteristics, safety profiles, and effectiveness as the predicate devices. Specific quantitative performance metrics (e.g., success rates, complication rates) are not provided for the DEPILASE TWIN LASE system itself, but rather inferred to be "comparable" to the predicates.
- Reported Device Performance: No specific quantitative performance data (e.g., success rates, adverse event rates from a study) are reported for the DEPILASE TWIN LASE Laser System in this document. The submission relies on the established performance and safety of the predicate devices.
Sample size used for the test set and the data provenance: Not applicable. The document does not describe a new clinical study with a test set of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth establishment is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
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, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser system; the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no new clinical study data presented requiring ground truth. The "ground truth" for the submission is the regulatory clearance and established safety/effectiveness of the predicate devices.
The sample size for the training set: Not applicable. No training set for a new algorithm or device development is mentioned.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text asserts substantial equivalence by comparing the DEPILASE TWIN LASE Laser System's intended use and technological characteristics to several already-cleared predicate lasers. It does not contain information about a specific study design with acceptance criteria, sample sizes, or ground truth establishment for a new clinical performance study of the device itself.

Summary

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Appendix E : 510 (k) Summary

020412 /

1. General Information:

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

FEB 2 2 2002### I. Description

The DEPILASE TWIN LASE Laser System is designed with 6 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 2 Hz.
d) An Alexandrite laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
e) Two optical delivery systems, interfacing the energy from each laser cavity to the patient via an indipendent optical fibre and focusing handpiece.
f) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

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020412

2/2

II. Intended Use

III. Summary of Substantial Equivalence

Depilase believes that its DEPILASE TWIN LASE Laser System is substantially equivalent, regarding the Nd: YAG laser emission, to the Laserscope Lyra (K990718), and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG Lasers previously cleared for both the coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types, and regarding the Alexandrite laser emission, to the Candela GenteLASE GL (K994260), GenteLASE II (K984601) and the Cynosure Apogee TSK (K992757) Alexandrite lasers, all previously cleared for the removal of unwanted hair in Fitzpatrick skin types I - IV

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

Technologically, the predicate devices have identical characteristics to the DEPILASE TWIN LASE Laser System, all comprising a flashlamp pumped Nd: YAG laser rod generating light at a wavelength of 1064 nm, or a flashlamp pumped Alexandrite laser rod generating light at a wavelength of 755 nm which is subsequently delivered to the patient via an individual optical fibre delivery system and focusing handpiece.

The DEPILASE TWIN LASE Laser System output characteristics are very similar to those of the 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 TWIN LASE 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 seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 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, NC 27709

Re: K020412

Trade/Device Name: Depilase Twin Lase 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: January 28, 2002 Received: February 7, 2002

Dear Ms. Gwynn:

We have reviewed your Section 510(k) premarket notification of intent to market the device t We nave reviewed your becaon 310(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars actual date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Led Ford Ford Food Dr conmieres prior to May 20, 1978, the can and with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosmetic Act (Act) that do not required to the general controls provisions of the Act. The 1 ou may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 IT your device is elassinod (600 as controls. Existing major regulations affecting your device can may oc subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oouv cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I Dri 3 issuanter or our device complies with other requirements of the Act that I DIT has made a and regulations administered by other Federal agencies. You must or any I cacial stututed and regarments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byevelles (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) 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 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

iriam C. Provost

ForCelia 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

K020412 510 (K) Number (if known): _

Device Name:

DEPILASE TWIN LASE LASER SYSTEM

Indications For Use:

The DEPILASE TWIN LASE 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.

Muram L. Provost

(Division Sign-Off -strative Division of Genera and Neurological L Juces

510(k) Number K020412

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

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.