510(k) K243035 · OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Ulthera® System
| Applicant | Ulthera, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Feb 24, 2025 |
| Received | Sep 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243035
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.