510(k) K140631 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
LUMENA FH HAIR REMOVAL SYSTEM
| Applicant | Shaser, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, May 16, 2014 |
| Received | Mar 12, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140631
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.