K250418
- 510(k) number
- K250418
- Device name
- Ulthera System (UC-1 Control Unit PRIME Model 2.1)
- Applicant
- Ulthera, Inc. NC · US
- Product code
- OHV — Focused Ultrasound For Tissue Heat Or Mechanical Cel
- Decision date
- 2025-05-13
- Date received
- 2025-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K250418.pdf
Official FDA record: K250418
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.