510(k) K231555 ยท OHS Light Based Over The Counter Wrinkle Reduction
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
| Applicant | iSMART Developments, Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Jul 27, 2023 |
| Received | May 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231555
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.