Approval or clearance ·
FDA cleared Ultherapy for the appearance of skin laxity on the knees
U.S. Food & Drug Administration · 510(k) K260618
510(k) K260618, "Ulthera System Expanded Indications (Knees)", decided May 21, 2026, adds the knees to the cleared indications. Merz announced it on August 11, 2026.
- What this source establishes
- That the cleared indications for this device now include the knees.
- What it does not establish
- Individual results, whether it suits a given person, or which operator credential a state requires.
Relates to Ultherapy (Ulthera System)
The official record (opens in a new tab) · Merz Aesthetics’s announcement (opens in a new tab) (the maker’s words, not the record) · checked Sep 25, 2026