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Radiancy Skinstation With Modified Light Unit Addembly

by Radiancy (Israel), Ltd.

510(k) K051671

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051671 Date2 Sep 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
FDA applicant
Radiancy (Israel) , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Powered Laser Surgical Instrument used for phototherapeutic light delivery in dermatological treatment, specifically hair removal. It utilizes a modified light unit assembly to deliver pulsed light energy to the skin surface, targeting hair follicles with controlled light pulses.

It is operated by clinicians in professional settings and was cleared via the FDA 510(k) process under K051671 with product code GEX. The device received a Substantially Equivalent decision on September 2, 2005, following a traditional review in the General & Plastic Surgery specialty.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Radiancy Skinstation with Modified Light Unit Assembly used for?

    It is a powered laser surgical instrument designed for phototherapeutic light delivery in dermatological treatment, specifically for hair removal by targeting hair follicles with controlled pulsed light energy.

  • How is the Radiancy Skinstation operated and who uses it?

    The device is operated by clinicians in professional settings such as dermatology clinics or medical spas, where trained professionals administer pulsed light treatments to patients.

  • What regulatory pathway was used for the Radiancy Skinstation and what was the outcome?

    It was cleared via the FDA 510(k) process under submission K051671, receiving a Substantially Equivalent decision on September 2, 2005, following a traditional review in the General & Plastic Surgery specialty.

  • What product code and classification apply to the Radiancy Skinstation?

    The device is classified under product code GEX, which corresponds to powered laser surgical instruments for dermatological use, as determined during its FDA 510(k) review.