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Visualase Thermal Therapy System

by Biotex, Inc. 2 variants

510(k) K081656

Visualase Thermal Therapy System is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Biotex, Inc., cleared under FDA 510(k) K081656 on 10 Sep 2008, 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 NumberK081656 Date10 Sep 2008ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-3251-2018 FDA Class II initiated 1 Jun 2018

    Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.

Timeline

2 dated events

  1. Cleared FDA 510(k) K081656
  2. Recall initiated FDA recalls Z-3251-2018

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  • Withdrawn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
LLZ
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

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

Cites

Cited by

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

Devices cleared under K081656

5 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K081656
UDI-DISize and differences
Visualase 002-1100
Medtronic Navigation Inc.
002-110000643169584440
Prescription: yes
No longer on the market
Visualase 9735542
Medtronic Navigation Inc.
973554200643169655935
Prescription: yes
No longer on the market
Visualase 9735542
Medtronic Navigation Inc.
973554200643169792890
Prescription: yes
No longer on the market
Visualase 9735552
Medtronic Navigation Inc.
973555200643169590076
Prescription: yes
On the market
Visualase 9735940
Medtronic Navigation Inc.
973594000643169878181
Prescription: no
On the market

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Biotex, Inc.

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