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CLEAR+BRILLIANT TOUCH® Laser System

by Solta Medical, Inc.

510(k) K223647

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 NumberK223647 Date29 Dec 2022ClearedStatusActive

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  • Withdrawn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, 19 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 Clear Brilliant Touch Laser System is a fractional laser device designed for dermatological procedures, specifically for soft tissue coagulation and general skin resurfacing. It employs dual wavelengths (1440 nm and 1927 nm) to target and treat skin at a cellular level, promoting rejuvenation and improving skin texture and tone.

This system is supplied as a medical device intended for use in clinical settings by trained professionals. It is classified under the FDA’s product code GEX and has received a 510(k) clearance as substantially equivalent to a predicate device. The device is not described as single-use or reusable in the provided data, nor are specific sterility or MRI safety details mentioned.

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Questions

AI-generated answers, 19 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 types of dermatological procedures is the Clear Brilliant Touch Laser System specifically designed for?

    The Clear Brilliant Touch Laser System is designed for soft tissue coagulation and general skin resurfacing. Its dual wavelengths (1440 nm and 1927 nm) allow it to target skin at a cellular level, making it suitable for skin rejuvenation and improving skin texture and tone. It is intended for use in clinical settings by trained professionals.

  • How is the Clear Brilliant Touch Laser System supplied, and where is it intended for use?

    The Clear Brilliant Touch Laser System is supplied as a medical device intended exclusively for use in clinical settings. It is not specified as single-use or reusable in the provided data, so its handling and maintenance would need to be determined by the manufacturer’s instructions for use.

  • What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its intended use?

    The Clear Brilliant Touch Laser System received FDA clearance through a 510(k) pathway, specifically under the product code GEX (General, Plastic Surgery). The clearance was granted as substantially equivalent to a predicate device, meaning it was determined to have the same intended use and technological characteristics as an existing approved device. This pathway ensures the device meets FDA safety and effectiveness standards for its dermatological applications.

  • Are there any specific details about the advisory committee or review process involved in the FDA clearance of this device?

    The device was reviewed by the FDA’s Skin and Soft Tissue Devices Advisory Committee (SU), which advises on general and plastic surgery-related devices. The review process was traditional, and the clearance decision was made on December 29, 2022, following a third-party review.