510(k) K212331 ยท PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use
BodySculp
| Applicant | Rohrer Aesthetics, LLC, Birmingham AL, US |
| Decision | Substantially Equivalent, Nov 9, 2021 |
| Received | Jul 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212331
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.