Ulthera, Inc.
Ulthera, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2026, with 1 FDA device recall on record.
Top product codes for Ulthera, Inc.
FDA recalls by Ulthera, Inc.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ulthera, Inc.
- K260618 — Ulthera® System
- K250418 — Ulthera System (UC-1 Control Unit PRIME Model 2.1)
- K243035 — Ulthera® System
- K233996 — Ulthera System (UC-1 Control Unit PRIME)
- K192185 — The Cellfina System
- K180623 — Ulthera System
- K161885 — The Cellfina System
- K153677 — The Cellfina System
- K150505 — Cellfina System
- K134032 — ULTHERA SYSTEM
- K132028 — ULTHERA SYSTEM
- K121700 — ULTHERA SYSTEM
- K122528 — ULTHERA SYSTEM
- DEN080006 — ULTHERA SYSTEM, MODEL 8850-0001
Data sourced from openFDA. This site is unofficial and independent of the FDA.