510(k) K191068 ยท PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Powersculp laser lipolysis system
| Applicant | Wuhan Lotuxs Technology Co., Ltd., East Lake High-Tech Development Zone, Wu, CN |
| Decision | Substantially Equivalent, Jul 17, 2019 |
| Received | Apr 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191068
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.