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Ultrabright (Microquartz Medical Side-Firing Laser Fiber)

by Microquartz Medical, Inc.

510(k) K953065

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 NumberK953065 Date27 Sep 1995ClearedStatusActive

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  • Withdrawn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, 21 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 device is a side-firing laser fiber used in powered laser surgical procedures, specifically classified under General and Plastic Surgery. It is designed to perform surgical laser procedures faster than flat tip fibers and is capable of being used in vaporization applications.

The device is supplied as a single-use surgical fiber intended for use in clinical settings where laser surgery is performed. It is manufactured by Microquartz Medical, Inc. and is regulated under product code GEX, with a 510(k) clearance number K953065. The device is classified as substantially equivalent and is intended for use in general and plastic surgery specialties.

Other devices from Microquartz Medical, Inc.

Questions

AI-generated answers, 21 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 surgical applications is the ULTRABRIGHT side‑firing laser fiber intended for?

    It is intended for powered laser procedures in general and plastic surgery, where a side‑firing tip can vaporize tissue more quickly than flat‑tip fibers, improving efficiency in procedures such as tissue ablation and contouring.

  • How is the ULTRABRIGHT laser fiber supplied and intended to be used?

    The product is supplied as a sterile, single‑use fiber that is opened only in the clinical setting. Because it is disposable, it eliminates the need for re‑processing and ensures consistent performance for each case.

  • Is the ULTRABRIGHT fiber sterile and what storage conditions are required?

    The fiber is provided sterile from the manufacturer. It should be stored in its original sealed packaging at room temperature, protected from moisture and direct sunlight, to maintain sterility until the point of use.

  • What regulatory pathway did the ULTRABRIGHT fiber follow?

    The device received a traditional 510(k) clearance (K953065) and is classified as substantially equivalent to existing devices under product code GEX, indicating it meets the FDA’s requirements for safety and effectiveness for its indicated uses.