510(k) K211402 ยท PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Powersculp laser lipolysis system
| Applicant | Lotuxs Medtech (Suzhou) Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Jul 30, 2021 |
| Received | May 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211402
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.