510(k) K030959 ยท GEX Powered Laser Surgical Instrument
BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100
| Applicant | Laser Peripherals, LLC, Golden Valley MN, US |
| Decision | Substantially Equivalent, Apr 25, 2003 |
| Received | Mar 27, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030959
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2014 | Laser Peripherals LLC LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO.
Laser surgical instrument for use in general and plastic surgery and in dermatology Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.