Ulthera® System— 510(k) K260618
Substantially EquivalentUlthera, Inc.
FDA 510(k) clearance K260618 for Ulthera® System, Substantially Equivalent on 2026-05-21. Applicant: Ulthera, Inc.. Device class: 2.
Summary
Ulthera's Ulthera System is filed under OHV, focused ultrasound for tissue heat or mechanical cellular disruption.
Class II, 21 CFR 878.4590. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Ulthera filed from Raleigh, North Carolina. The decision came 85 calendar days after receipt (February 25 to May 21, 2026).
Clearance details
- Applicant
- Ulthera, Inc.
- Product code
- Product 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
- Raleigh, NC, US
Recent devices under product code OHV
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