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RevLight Skin Care System

by Skincare Technology, Inc.

510(k) K042630

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 NumberK042630 Date27 Jun 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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The RevLight Skin Care System is an LED phototherapy device that delivers light to the skin. It consists of a base unit for power and control, along with detachable Pulsators that are moved over the skin surface by the user or clinician.

The system is supplied as a complete unit with base and Pulsators. It is intended for LED phototherapy applications. The device has FDA 510(k) clearance with product code GEX and is substantially equivalent to other cleared LED systems.

Questions

AI-generated answers, 25 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 RevLight Skin Care System used for?

    The RevLight Skin Care System is an LED phototherapy device designed to deliver light to the skin surface. It consists of a base unit for power and control, along with detachable Pulsators that are moved over the skin by the user or clinician for LED phototherapy applications.

  • How is the RevLight Skin Care System supplied?

    The system is supplied as a complete unit that includes both the base unit and the detachable Pulsators. This comprehensive setup provides everything needed for LED phototherapy treatments according to the manufacturer's specifications.

  • What is the regulatory status of the RevLight Skin Care System?

    The RevLight Skin Care System has FDA 510(k) clearance with product code GEX. It is classified as substantially equivalent to other cleared LED systems, with a decision date of June 27, 2005, and was reviewed under the General, Plastic Surgery advisory committee.

  • Is the RevLight Skin Care System reusable or single-use?

    The RevLight Skin Care System is designed for multiple uses as it consists of a base unit and detachable Pulsators that can be used repeatedly for LED phototherapy treatments. The device is not indicated as single-use equipment.