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Bwf-5 Medical Laser Series, 810 Nm; 930 Nm; 980 Nm; 1080 Nm

by B&W Tek, Inc.

510(k) K062363

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 NumberK062363 Date17 Jan 2007ClearedStatusActive

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 BWF-5 Medical Laser Series is a class of surgical lasers designed for soft tissue treatment. It delivers laser light at wavelengths of 810 nm, 930 nm, 980 nm, and 1080 nm in both contact and non-contact modes, including through endoscopic, introducer, or catheter-based applications.

This device is supplied as a reusable medical instrument and is intended for use in surgical settings. It holds an FDA 510(k) clearance under the product code GEX, with a decision classification of Substantially Equivalent to a predicate device. No specific sterility or MRI safety information is provided in the available data.