510(k) K082721 ยท GEX Powered Laser Surgical Instrument
LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
| Applicant | Photo Medex, Inc., Montgomeryville PA, US |
| Decision | Substantially Equivalent, Oct 28, 2008 |
| Received | Sep 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082721
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2013 | PhotoMedex, Inc. The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***.
The product is packaged in a flexible pouch and in Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.