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Fencer 308 Excimer Laser System

by Kera Harvest/Laser Max Medical Technologies Corp

510(k) K080975

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 NumberK080975 Date15 Jul 2008ClearedStatusActive

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  • Withdrawn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, 24 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 Fencer 308 Excimer Laser System is a powered laser surgical instrument that emits 308 nm ultraviolet light for the treatment of skin conditions. It is indicated for use in dermatology to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma by delivering targeted phototherapy to affected skin areas.

The device is operated by healthcare professionals in clinical settings. It is supplied as a reusable system and has received FDA 510(k) clearance under K080975 with product code GEX. The system is classified as a General, Plastic Surgery device and was determined to be substantially equivalent on July 15, 2008.

Questions

AI-generated answers, 24 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 Fencer 308 Excimer Laser System used for?

    The Fencer 308 Excimer Laser System is used to treat skin conditions such as psoriasis, vitiligo, atopic dermatitis, and leukoderma by delivering targeted 308 nm ultraviolet light to affected areas. This phototherapy approach allows healthcare professionals to precisely treat localized lesions while minimizing exposure to surrounding healthy skin.

  • Is the Fencer 308 Excimer Laser System reusable or single-use?

    The Fencer 308 Excimer Laser System is supplied as a reusable system, meaning it is designed for multiple uses after proper cleaning and maintenance between treatments. This allows healthcare facilities to use the device repeatedly for patient treatments over its operational lifespan, provided it is handled according to the manufacturer's reprocessing instructions.

  • What regulatory clearance does the Fencer 308 Excimer Laser System have?

    The Fencer 308 Excimer Laser System has received FDA 510(k) clearance under submission number K080975, with product code GEX. It was determined to be substantially equivalent to a predicate device on July 15, 2008, and is classified as a General, Plastic Surgery device. This clearance permits its marketing for the indicated dermatological uses in the United States.