Ulthera® System— 510(k) K260618

Substantially Equivalent

Ulthera, Inc.

FDA 510(k) clearance K260618 for Ulthera® System, Substantially Equivalent on 2026-05-21. Applicant: Ulthera, Inc..

Clearance details

Applicant: Ulthera, Inc.
Product code: Code OHV
Advisory panel: General, Plastic Surgery
Date received: 2026-02-25
Decision date: 2026-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

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