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Visualase Thermal Therapy System

by Biotex, Inc. 2 variants

510(k) K071328

Visualase Thermal Therapy System is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Biotex, Inc., cleared under FDA 510(k) K071328 on 31 Aug 2007, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071328 Date31 Aug 2007ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1905-2020 FDA Class II initiated 8 Jul 2019

    The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.

Timeline

2 dated events

  1. Cleared FDA 510(k) K071328
  2. Recall initiated FDA recalls Z-1905-2020

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  • Withdrawn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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

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