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UltraClear Fractional Laser System

by Fa International, LP 510(k)

Active United States

510(k) K210847

Overview

The UltraClear Fractional Laser System is a surgical device designed for use in plastic surgery procedures. It is a fractional laser system that performs ablative treatments on skin tissue.

The device is supplied by Fa International, LP and received FDA 510(k) clearance on December 10, 2021, with product code GEX. It is intended for use in general and plastic surgery settings under the regulatory category of surgical devices.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210847 Date10 Dec 2021ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Questions

  • What is the UltraClear Fractional Laser System used for?

    The UltraClear Fractional Laser System is a surgical device designed for ablative treatments on skin tissue in plastic surgery procedures. It is intended for use in general and plastic surgery settings.

  • How is the UltraClear Fractional Laser System supplied?

    The device is supplied by Fa International, LP. It is a surgical device that requires proper handling and storage according to manufacturer guidelines to maintain its functionality and safety.

  • What is the regulatory status of the UltraClear Fractional Laser System?

    The UltraClear Fractional Laser System received FDA 510(k) clearance on December 10, 2021, with product code GEX. It is categorized as a surgical device under the regulatory review of the General and Plastic Surgery advisory committee.

  • Is the UltraClear Fractional Laser System reusable or single-use?

    The device data does not specify whether the UltraClear Fractional Laser System is reusable or single-use. This information would be detailed in the manufacturer's instructions for use, which should be consulted for proper handling protocols.