K233996
- 510(k) number
- K233996
- Device name
- Ulthera System (UC-1 Control Unit PRIME)
- Applicant
- Ulthera, Inc. AZ · US
- Product code
- OHV — Focused Ultrasound For Tissue Heat Or Mechanical Cel
- Decision date
- 2024-02-22
- Date received
- 2023-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233996.pdf
Official FDA record: K233996
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.