510(k) K102639 ยท GEX Powered Laser Surgical Instrument
SL3
| Applicant | Discus Dental, LLC, Culver City CA, US |
| Decision | Substantially Equivalent, Dec 1, 2010 |
| Received | Sep 14, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102639
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2013 | Discus Dental LLC SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232.
The SL3 is a soft-tissue diode laser intended to be used for dental procedures Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.