510(k) K053087 ยท GEX Powered Laser Surgical Instrument
VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM
| Applicant | Biotex, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Mar 1, 2006 |
| Received | Nov 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053087
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2022 | Medtronic Navigation, Inc. Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE
FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures. Open, Classified |
ONO | None listed |
| Mar 23, 2018 | Medtronic Navigation, Inc. Visualase Cooled Laser Applicator System (VCLAS) labeled as:
a. Part Number 9735559, Visualase Cooled Laser Applicator System 3mm Tip;
b. Part Number 9735560 Visualase Cooled Laser Applicator Sys Terminated |
GEX | None listed |
| Jul 27, 2017 | Medtronic Navigation, Inc. VCLAS (Visualase Cooled Laser Ablation System)
Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip;
Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip;
Part N Terminated |
GEX | None listed |
| Jul 3, 2017 | Medtronic Navigation, Inc. Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Terminated |
GEX | None listed |
| May 16, 2016 | Medtronic Navigation, Inc. Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS).
The LDF and disposables (in Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.