510(k) K181298 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Harmony XL Multi-Application Platform
| Applicant | Alma Lasers, Inc., Buffalo Grove IL, US |
| Decision | Substantially Equivalent, Jun 13, 2018 |
| Received | May 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181298
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.