The SkinStation is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.

Device Description

The Skin Station that is the subject of this 510(k) notice is the exact same device as the cleared Skin Station except for the addition of a light unit assembly specifically for hair removal in Fitzpatrick Skin Types V and VI.

AI/ML Overview

The provided text is a 510(k) summary for the Radiancy SkinStation Photoepilation System with Modified Light Unit Assembly for Hair Removal. This document focuses on demonstrating substantial equivalence to predicate devices for a specific medical device. It does not include details about acceptance criteria, study designs, sample sizes for training or test sets, expert qualifications, or ground truth establishment in the manner typically associated with AI/ML device evaluations.

Therefore, most of the requested information cannot be extracted from this document because it describes a traditional medical device (a light-based hair removal system) and its regulatory submission, not a software as a medical device (SaMD) or an AI/ML-powered device. The study mentioned is a clinical data study to show the device's effectiveness for hair removal in specific skin types, not an "AI evaluation study."

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance:

This information is typically found in the clinical study results section of a 510(k) submission when performance metrics are explicitly defined. The provided summary states: "Clinical data demonstrates that the Radiancy SkinStation removes unwanted body and/or facial hair in adults with Fitzpatrick skin types V-VI with only minor side effects."
However, it does not state specific quantitative acceptance criteria (e.g., "X% hair reduction required") or detailed performance metrics.

Acceptance Criteria (Not explicitly stated as such, but inferred goal)	Reported Device Performance
Effective removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types V-VI	Clinical data demonstrates that the Radiancy SkinStation removes unwanted body and/or facial hair in adults with Fitzpatrick skin types V-VI
Only minor side effects	Clinical data demonstrates "only minor side effects"

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

Sample Size for Test Set: Not specified in the provided summary.
Data Provenance: Not specified in the provided summary.
Retrospective or Prospective: Not specified in the provided summary, but clinical trials for device approval are typically prospective.

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):

This question is not applicable to this type of device and study. The "ground truth" for a hair removal device is the actual hair reduction observed clinically, assessed by practitioners and potentially by patients, not by experts establishing a categorical ground truth like in AI/ML image analysis. No details about "experts" establishing ground truth are provided.

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

Not applicable. This concept is relevant for AI/ML studies where multiple human readers review cases to establish a consensus ground truth. For a hair removal device, performance is typically assessed by clinical observation of hair reduction and adverse events.

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 is an AI/ML specific study type. The device is a direct treatment device, not an AI assistant for human readers.

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

Not applicable. This device is a hardware-based system. "Standalone" performance generally refers to an algorithm's performance without human interaction, which doesn't fit a physical light-based hair removal system.

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

Based on the context of a hair removal device, the "ground truth" would implicitly be outcomes data related to hair reduction and adverse events observed clinically.

8. The sample size for the training set:

Not applicable. This device does not use a "training set" in the context of AI/ML.

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

Not applicable. This device does not use a "training set" in the context of AI/ML.

Summary

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510(k) SUMMARY

KOSI671

Radiancy (Israel) Ltd.'s Radiancy SkinStation® Photoepilation System with Modified Light Unit Assembly for Hair Removal

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Manufacturer:	Radiancy (Israel) Ltd.9 Gan Rave StreetIndustrial ParkYavneIsrael

Telephone:Facsimile:	+972-8-9438010+972-8-9438020

Contact Person:	Jonathan S. Kahan, Esq.Regulatory CounselHogan & Hartson L.L.P.555 Thirteenth Street, N.W.Washington, D.C. 20004-1109Telephone: (202) 637-5794Facsimile: (202) 637-5910Email: JSKahan@HHLaw.com
Date Prepared:	June 22, 2005

Name of Device and Name/Address of Sponsor

Trade/Proprietary Name:	Radiancy SkinStation with Modified LUA
Common Name:	Pulsed Light System and Light Unit Assembly
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology (21 C.F.R. § 878.4810)

Manufacturing Facility:	Radiancy (Israel) Ltd.
	9 Gan Rave Street
	Industrial Park
	Yavne, Israel

Establishment
Registration Number:	9616256
Owner/operator number:	9040071

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Predicate Devices

Radiancy SkinStation Photoepilation Systems

AesThera Corporation, Model AIP

Medical Bio Care Sweden AB., ProLite

Palomar Medical Technologies, Inc., StarLux

Intended Use / Indications for Use

Technological Characteristics

Substantial Equivalence

The Radiancy SkinStation, as modified, has the same intended use and very similar indications for use, principles of operation and technological characteristics as the cleared Radiancy SkinStation, and with the AesThera Corporation Model AIP, Medical Bio Care Sweden AB. ProLite, and the Palomar Medical Technologies, Inc., StarLux. The minor difference between the Radiancy SkinStation and the predicates do not raise new issues of safety and effectiveness. Clinical data demonstrates that the Radiancy SkinStation removes unwanted body and/or facial hair in adults with Fitzpatrick skin types V-VI with only minor side effects. Thus, the Radiancy SkinStation are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and entwined snakes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 2 2005

Radiancy (Israel) Ltd. c/o Mr. Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street Washington, D.C. 20004-1109

Re: K051671

Trade/Device Name: Radiancy Skin Station with Modified Light Unit Assembly 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: June 22, 2005 Received: June 22, 2005

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave ro rowed your 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 conniner to Has) 2018-11-19, 2018 11:15 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- Mr. Jonathan S. Kahan, Esq.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manisang of substantial equivalence of your device to a legally premaired 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 If you desire specific acrive int 3 %. (240) 276-0115. Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Sincerely, yours,

Barbara Buchnd
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Indications for Use Form

510(k) Number (if known):	K051671
Device Name:	Radiancy SkinStation with Modified Light Unit Assembly
Indications for Use:

Prescription Use _X

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 C F.R. 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aubare Preelunds for mXm
Division Sign Off

peral. Restorative, Division of Ge and Neurological De

510(k) Number K051671

\\PH - 69039/0002 - 19155 v1

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.