510(k) K230100 ยท OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
SCIZER (SC1-M410)
| Applicant | Classys, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Nov 3, 2023 |
| Received | Jan 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230100
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.