510(k) K992866 ยท GEX Powered Laser Surgical Instrument
OPTILITE IX LASER SURGERY ACCESSORIES
| Applicant | Convergent Laser Technologies, Oakland CA, US |
| Decision | Substantially Equivalent, Nov 18, 1999 |
| Received | Aug 25, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2019 | Xintec Corp OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only Terminated |
GEX | None listed |
| Jun 23, 2017 | Xintec Corp OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES
The Odyssey 30B is approved for numerous medical pr Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.