510(k) K071328 ยท GEX Powered Laser Surgical Instrument
VISUALASE THERMAL THERAPY SYSTEM
| Applicant | Biotex, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Aug 31, 2007 |
| Received | May 11, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071328
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2019 | Medtronic Navigation, Inc. Visualase Cooled Laser Applicator System Tubing Set kits
Product numbers:
VCLAS 9735559, 3mm tip/1.65mm catheter
VCLAS 9735560, 10mm tip/1.65mm catheter
VCLAS 9735561, 15mm tip/1.85mm catheter Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.