ULTHERA SYSTEM— 510(k) K134032
Substantially EquivalentUlthera, Inc.
FDA 510(k) clearance K134032 for ULTHERA SYSTEM, Substantially Equivalent on 2014-06-20. Applicant: Ulthera, Inc.. Device class: 2.
Clearance details
- Applicant
- Ulthera, Inc.
- Product code
- Code OHV
- Device class
- Class 2
- Regulation
- 21 CFR 878.4590
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mesa, AZ, US
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