510(k) K260618 · OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Ulthera® System
| Applicant | Ulthera, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, May 21, 2026 |
| Received | Feb 25, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260618
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.