510(k) K160968 ยท OHT Light Based Over-The-Counter Hair Removal
iPulse SmoothSkin Gold Hair Removal Device
| Applicant | Cyden Limited, Swansea, GB |
| Decision | Substantially Equivalent, Apr 14, 2016 |
| Received | Apr 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160968
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.