ULTHERA SYSTEM
FDA 510(k) clearance K121700 · decided 2012-10-02
Clearance details
- K-number
- K121700
- Device name
- ULTHERA SYSTEM
- Applicant
- Ulthera, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-07
- Decision date
- 2012-10-02
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- OHV
- Device class
- 2
- Regulation number
- 878.4590
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mesa, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.