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Ulthera, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K260618 Ulthera® SystemOHV2026-05-21 View
510(k) K250418 Ulthera System (UC-1 Control Unit PRIME Model 2.1)OHV2025-05-13 View
510(k) K243035 Ulthera® SystemOHV2025-02-24 View
510(k) K233996 Ulthera System (UC-1 Control Unit PRIME)OHV2024-02-22 View
510(k) K192185 The Cellfina SystemOUP2019-10-09 View
510(k) K180623 Ulthera SystemOHV2018-05-04 View
510(k) K161885 The Cellfina SystemOUP2016-10-05 View
510(k) K153677 The Cellfina SystemOUP2016-02-25 View
510(k) K132028 ULTHERA SYSTEMOHV2013-12-11 View
510(k) K121700 ULTHERA SYSTEMOHV2012-10-02 View
510(k) K122528 ULTHERA SYSTEMOHV2012-08-28 View
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