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Fraxel SR Laser System

by Reliant Technologies, Inc. 2 variants

510(k) K053047

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 NumberK053047 Date20 Mar 2006ClearedStatusActive

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  • Withdrawn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, 27 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 Fraxel SR Laser System is a dermatological laser system that uses scanning and focusing optics to deliver a pattern of thermal energy. It is intended for use in dermatological procedures requiring the coagulation of soft tissue, treatment of periorbital wrinkles, treatment of surgical scars and acne scars, and photocoagulation of pigmented lesions such as lentigos.

The system is supplied by Reliant Technologies, Inc. and has received FDA 510(k) clearance with the number K053047. It is intended for use in clinical settings and is regulated as a medical device for dermatological applications.

Other devices from Reliant Technologies, Inc.

See all devices from Reliant Technologies, Inc. →

Questions

AI-generated answers, 27 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 Fraxel SR Laser System used for?

    The Fraxel SR Laser System is a dermatological device that uses scanning and focusing optics to deliver thermal energy for treating periorbital wrinkles, surgical scars, acne scars, and pigmented lesions like lentigos through coagulation of soft tissue.

  • How is the Fraxel SR Laser System supplied?

    The Fraxel SR Laser System is supplied by Reliant Technologies, Inc. It is intended for use in clinical settings and is regulated as a medical device specifically for dermatological applications.

  • What regulatory clearance has the Fraxel SR Laser System received?

    The Fraxel SR Laser System has received FDA 510(k) clearance with the number K053047, making it substantially equivalent to other devices for its intended dermatological uses.

  • What are the key specifications of the Fraxel SR Laser System?

    The Fraxel SR Laser System is classified under product code GEX and was reviewed by the General, Plastic Surgery advisory committee. It received FDA clearance on March 20, 2006, after being submitted on October 28, 2005.