The THERMALIGHT®® 2000 is indicated for removal of unwanted body hair through the application of pulsed light energy applied to the hair follicle at the surface of the skin (non-invasive photo-epilation).

Device Description

The Thermalight2000 is an instrument which is designed to painlessly, safely, and effectively remove hair by the application of pulsed light energy to the hair follicle. It operates similar to needle electrolysis machine in that it removes hair, one hair at a time by thermolysis. Using the Thermalight2000, thermolysis is achieved by the application of light energy to the hair growth support tissue instead of the application of electrical energy employed by conventional needle electrolysis units.

AI/ML Overview

The provided text is a 510(k) premarket notification for the THERMALIGHT® 2000 device, an epilator. This type of document focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed clinical study with acceptance criteria and performance metrics typically found in efficacy trials.

Therefore, the requested information regarding acceptance criteria, device performance, study design, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details cannot be fully provided from the given text.

Here's an analysis of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly available in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device (D' Plume XXII Photocoagulator - K895687) rather than meeting specific performance acceptance criteria for a new clinical claim. The "performance" mentioned is primarily about its operational similarity and improved reliability/economy due to modern design, not specific clinical outcomes with predefined thresholds.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified clinical outcome metrics like hair reduction percentage, pain scores, or adverse event rates with specific targets.

The text states:

"The THERMALIGHT®® 2000 incorporates more modern design techniques and newer components which provide a more reliable unit, with more economical, and more consistent performance." (This is a general statement, not a quantified performance metric against an acceptance criterion).
"Unlike the machines which treat large areas at a time, the THERMALIGHT®® 2000 is safe and can not generate enough power to damage the skin. The light energy is applied by means of a optical fiber tip which is placed at the entrance to the hair follicle. The tip never enters below the skin. There is no pain, no skin damage, and there is no risk of introducing disease." (These are safety claims, not quantitative performance data against specific criteria).

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided text.

The document does not describe a specific clinical "test set" or a study designed to evaluate the device's efficacy in terms of hair removal. It's a regulatory submission for substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable/available.

Since no specific test set or clinical study for efficacy is described, there is no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable/available.

No adjudication method is mentioned as there is no described test set or clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not available/applicable.

The document is a 510(k) submission, not a report of a clinical efficacy trial, and therefore does not discuss MRMC studies or human reader improvement with AI. The device described is an epilator, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Not directly available in the provided text.

Again, the focus is on substantial equivalence to an existing device, not a standalone performance study in the way one would evaluate an AI algorithm. The closest information is the safety claim that "the THERMALIGHT®® 2000 is safe and can not generate enough power to damage the skin." However, this is not a detailed performance study.

7. Type of Ground Truth Used

Not applicable/available.

There is no described clinical study or ground truth for performance. The "ground truth" for the 510(k) pathway is that the device is "substantially equivalent" to a legally marketed predicate device, relying on design and intended use similarities.

8. Sample Size for the Training Set

Not applicable/available.

This is not an AI/ML device, so there is no concept of a "training set" in the context of the provided document.

9. How the Ground Truth for the Training Set Was Established

Not applicable/available.

As above, this is not an AI/ML device.

Summary

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SEP 1 0 1999

K992630

Jennifer MAXX 150 Fifth Avenue New York, NY 10010 212 645 9212

SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR IDENTIFICATION: A.

Jennifer Maxx, Inc. 150 Fifth Avenue, Suite 218 New York City, NY 10011 Telephone: 212 645-9212

ESTABLISHMENT REGISTRATION NUMBER: Pending B.

OFFICIAL CONTACT PERSON C.

Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854 Tel. : (301) 279 -2899 Fax : (301) 294-0126

D. DATE OF PREPARATION OF THIS SUMMARY: September 2, 1999

0:00005

PROPRIETARY (TRADE) NAME: THERMALIGHT®® 2000 E.

COMMON NAME: Epilator F.
G. CLASSIFICATION NAME AND REFERENCE : Unclassified
PROPOSED REGULATORY CLASS: н.

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DEVICE PRODUCT CODE: I.

PANEL: General & Plastic Surgery J.

DESCRIPTION OF DEVICE: K.

INTENDED USE: L.

The THERMALIGHT® 2000 is intended to destroy the dermal papilla of a hair.

INDICATIONS FOR USE: M.

PREDICATE DEVICE: N.

The THERMALIGHT®® 2000 is substantially equivalent to the D' Plume XXII Photocoagulator (Epilation Machine) (K895687)

0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Both the THERMALIGHT®® 2000 and the D' Plume XXII Photocoagulator (Epilation Machine) (K895687) have the same intended use and both are indicated for removal of unwanted body hair through the application of pulsed light energy applied to the hair follicle at the surface of the skin (non-invasive photo-epilation). The

THERMALIGHT®® 2000 treats one hair at a time just as does conventional needle electrolysis and as does the D' Plume XXII Photocoagulator. Both machines employ a power supply to charge an energy storage device, feeding a xenon pulsed light source to produce a visible light energy pulse. Both machines also employ an optical fiber to conduct the light from the xenon flash lamp to the surface of the skin. The energy delivered to the skin surface is identical and the usage of the two units are identical. The THERMALIGHT®® 2000 incorporates more modern design techniques and newer components which provide a more reliable unit, with more economical, and more consistent performance.

P. SAFETY:

Unlike the machines which treat large areas at a time, the THERMALIGHT®® 2000 is safe and can not generate enough power to damage the skin. The light energy is applied by means of a optical fiber tip which is placed at the entrance to the hair follicle. The tip never enters below the skin. There is no pain, no skin damage, and there is no risk of introducing disease.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1999

Jennifer Maxx, Inc. c/o Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K992630 Trade Name: Thermalight 2000 Regulatory Class: II Product Code: GEX and KNW Dated: June 14, 1999

Received: June 15, 1999

Dear Dr. Estrin:

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 requirement, 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Norman F. Estrin, Ph.D., RAC

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 vour 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.

picasso

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

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CONFIDENTIAL

Page 1 of 1

510(k) Number: K992630

Device Name: THERMALIGHT 2000

Indications for Use:

The THERMALIGHT 2000 is indicated for removal of unwanted body hair through the application of pulsed light energy applied to the hair follicle at the surface of the skin (noninvasive photo-epilation).

(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

(Optional Format 1-2-96)

(Division)Sign-Off Division of General Restorative Devices 510(k) Numbe

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.