510(k) K041957 ยท GEX Powered Laser Surgical Instrument
EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
| Applicant | Diomed, Inc., North Reading MA, US |
| Decision | Substantially Equivalent, Dec 1, 2004 |
| Received | Jul 21, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041957
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2022 | Angiodynamics, Inc. VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM
Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins. Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.