LIGHT AGE EPICARE ALEXANDRITE LASER by LIGHT AGE, INC.

The Light Age EpiCare™ Alexandrite Laser is a medical device capable of emitting an invisible pulsed treatment laser beam with a wavelength of 755 mm under the guidance of a visible aiming beam. This laser can be utilized in either a continuous or timed-exposure mode of operation.

AI/ML Overview

The provided text describes a 510(k) summary for the Light Age EpiCare™ Alexandrite Laser, claiming substantial equivalence to a predicate device, the Sharplan Model 5000 Alexandrite Laser System.

Based on the provided text, the following information regarding acceptance criteria and studies is available:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate device (Sharplan Model 5000 Alexandrite Laser System) in design and clinical perspective.	The Light Age EpiCare™ Alexandrite Laser is stated to be of "identical design" and have the "same intended use" as the predicate device. Light Age, Inc. previously supplied internal components for the Sharplan Model 5000 and is now taking over final assembly, sales, and distribution without product changes or new indications.
Intended use: removal of dark, unwanted body hair.	The device is intended "for use in dermatology for the removal of dark, unwanted body hair."
Safety and effectiveness.	"The safety and effectiveness of the Light Age EpiCare™ Alexandrite Laser is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device..." The document asserts that "As the predicate and candidate devices are identical in design and overall performance characteristics, the Light Age EpiCare™ Alexandrite Laser should not raise any concerns regarding its overall safety or effectiveness."
Wavelength: 755 mm.	The device emits an "invisible pulsed treatment laser beam with a wavelength of 755 mm."
Operation mode: continuous or timed-exposure.	The device "can be utilized in either a continuous or timed-exposure mode of operation."

Sample size used for the test set and the data provenance:

The document does not describe a specific test set or clinical study conducted for the Light Age EpiCare™ Alexandrite Laser itself. Instead, it relies on the safety and effectiveness data of the predicate device, the Sharplan Model 5000 Alexandrite Laser System, which FDA reviewed under K973354 and K971874. A letter of authorization from ESC Medical Systems was provided to allow FDA access to this predicate data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no new clinical study data for the Light Age EpiCare™ Alexandrite Laser is presented or described in this 510(k) summary. The determination is based on the previously established ground truth for the predicate device, which is not detailed here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no new clinical study data for the Light Age EpiCare™ Alexandrite Laser is presented or described in this 510(k) summary.
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. The device is a medical laser for hair removal, not an AI-assisted diagnostic or imaging tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a medical laser, not an algorithm. Performance is assessed based on its physical characteristics and equivalence to the predicate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the Light Age EpiCare™ Alexandrite Laser, the "ground truth" for its safety and effectiveness is established by its substantial equivalence to the predicate device, the Sharplan Model 5000 Alexandrite Laser System, along with the safety and effectiveness data previously submitted for that predicate device (K973354, K971874). The specific types of ground truth (e.g., patient outcomes, clinical measurements) used in the predicate device's evaluation are not detailed in this summary.
The sample size for the training set:

Not applicable. The device is a physical medical laser, not a machine learning model requiring a training set.
How the ground truth for the training set was established:

Not applicable, for the same reason as point 8.

Summary

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

Page E2

JAN 7 1999

K9839777

510(k) Summary of Safety and Effectiveness Light Age. Inc. EpiCare™ Alexandrite Laser

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information on which the substantial equivalence determination is based.

The safety and effectiveness of the Light Age EpiCare™ Alexandrite Laser is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device, which is the Sharplan Model 5000 Alexandrite Laser System.

1. Light Age, Inc. 2 Riverview Drive Somerset, NJ 08873 Susan Laufer, Director of Regulatory Affairs November 5, 1998
1. Model: Light Age EpiCare™ Alexandrite Laser
Predicate Device: The Sharplan Model 5000 Alexandrite Laser System (K973354, K971874) 3.
1. Description: The Light Age EpiCare™ Alexandrite Laser is a medical device capable of emitting an invisible pulsed treatment laser beam with a wavelength of 755 mm under the guidance of a visible aiming beam. This laser can be utilized in either a continuous or timed-exposure mode of operation.
The Light Age EpiCare™ Alexandrite Laser is intended for use in dermatology for the removal of న్. dark, unwanted body hair.
1. From both a design and clinical perspective, the predicate and candidate devices are of identical design and have the same intended use. Light Age has been supplying Laser Industries, Ltd. with the internal components of the Sharplan Model 5000 Alexandrite Laser System and integrating them into the basic Laser Industries chassis and power supply since the start of the Model 5000 project. Light Age is now taking over the final assembly, sales, and distribution of this laser. No changes will be made to the product, and Light Age is seeking no new indications in this 510(k) submission.

A letter of authorization from ESC Medical Systems (the parent company of Laser Industries, Ltd. and Sharplan Lasers, Inc.) is provided in Section A of this document, to permit the FDA to access the data contained in K973354 and K971874 in support of this premarket notification.

As the predicate and candidate devices are identical in design and overall performance characteristics, the Light Age EpiCare™ Alexandrite Laser should not raise any concerns regarding its overall safety or effectiveness.

Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.

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

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1999 JAN

Ms. Susan Laufer Director of Regulatory Affairs Light Age, Inc. Two Riverview Drive Somerset, New Jersey 08873

K983977 Re: Trade Name: Light Age EpiCare™ Alexandrite Laser Regulatory Class: II Product Code: GEX Dated: November 5, 1998 Received: November 9, 1998

Dear Ms. Laufer:

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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.

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

Page 2 - Ms. Susan Laufer

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 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 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,

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

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

510(k) Number (If known): ____________________________________________________________________________________________________________________________________________________ K983977

Light Age EpiCare™ Alexandrite Laser Device Name:

Indications for Use:

The Light Age EpiCare™ Alexandrite Laser is intended for use in dermatology for the removal of dark, unwanted body hair.

(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)

pcoello

Divisi Division of General Restora 510(k) Numb

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.