510(k) K161046 ยท OAP Laser, Comb, Hair
Laser Helmet LH40-EVO
| Applicant | Theradome, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, May 12, 2016 |
| Received | Apr 13, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161046
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.