Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of MerzLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Ulthera with 13 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated May 21, 2026: Ulthera® System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 21, 2026 | Ulthera® SystemK260618 · OHV | 510(k) clearances |
| May 13, 2025 | Ulthera System (UC-1 Control Unit PRIME Model 2.1)K250418 · OHV | 510(k) clearances |
| Feb 24, 2025 | Ulthera® SystemK243035 · OHV | 510(k) clearances |
| Feb 22, 2024 | Ulthera System (UC-1 Control Unit PRIME)K233996 · OHV | 510(k) clearances |
| Oct 9, 2019 | The Cellfina SystemK192185 · OUP | 510(k) clearances |
| May 4, 2018 | Ulthera SystemK180623 · OHV | 510(k) clearances |
| Nov 14, 2016 | Cellfina Prep Pack, Part No. CP1Class II · It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) de | Device recalls |
| Oct 5, 2016 | The Cellfina SystemK161885 · OUP | 510(k) clearances |
| Feb 25, 2016 | The Cellfina SystemK153677 · OUP | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
