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Chromalume Turbo Light Source With Xtremebeam Fiber Optic Headlampfst Model Fst

by Bfw, Inc.

510(k) K093386

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093386 Date28 Jan 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
FST
Device Class
Class II
Regulation
21 CFR Part 878.4580
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.

This device is a light, surgical, fiberoptic, as defined in the device type and nomenclature authority. It consists of a Chromalume Turbo Light Source with an Xtremebeam Fiber Optic Headlamp, designed to provide illumination for surgical procedures via fiber optic transmission.

The device accommodates fiber optic cables from Wolf, Storz, Olympus, and ACMI/BFW products. The Xtremebeam Fiber Optic Headlamp is a passive luminary illuminated by the fiber optic light source to deliver supplemental light during surgery. It received FDA 510(k) clearance under K093386 as substantially equivalent to a predicate device, with product code FST and classification under regulation number 878.4580 for general and plastic surgery use.

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 is the Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlamp used for?

    This device is designed to provide illumination for surgical procedures via fiber optic transmission, delivering supplemental light during surgery through the passive Xtremebeam Fiber Optic Headlamp, which is illuminated by the fiber optic light source.

  • Which fiber optic cables is the Chromalume Turbo Light Source compatible with?

    The device accommodates fiber optic cables from Wolf, Storz, Olympus, and ACMI/BFW products, allowing flexibility in surgical settings where these systems are used.

  • Is the Xtremebeam Fiber Optic Headlamp a reusable or single-use component?

    The Xtremebeam Fiber Optic Headlamp is a passive luminary, meaning it does not generate light itself but transmits light from the source; it is designed for reuse as part of the surgical light system, not as a disposable item.

  • What regulatory pathway was used for the Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlamp?

    The device received FDA 510(k) clearance under K093386 as substantially equivalent to a predicate device, with product code FST and classified under regulation number 878.4580 for general and plastic surgery use.