510(k) K141237 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
HARMONY LITE
| Applicant | Alma, Inc., Homosassa FL, US |
| Decision | Substantially Equivalent, Mar 13, 2015 |
| Received | May 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141237
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.