Ulthera, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Ulthera, Inc.” (first 2012, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Since 2017 the median was 76 days, against 88 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 62 |
| 2013 | 1 | 163 |
| 2014 | 1 | 171 |
| 2015 | 1 | 154 |
| 2016 | 2 | 76 |
| 2017 | 0 | — |
| 2018 | 1 | 56 |
| 2019 | 1 | 58 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 66 |
| 2025 | 2 | 120 |
| 2026 | 1 | 85 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ulthera, Inc. took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 10 | 9 |
| OUP | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | 4 | 4 |
Review panels
Most recent Ulthera, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260618 | Ulthera® System | OHV | 2026-05-21 | 85 |
| K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | OHV | 2025-05-13 | 89 |
| K243035 | Ulthera® System | OHV | 2025-02-24 | 150 |
| K233996 | Ulthera System (UC-1 Control Unit PRIME) | OHV | 2024-02-22 | 66 |
| K192185 | The Cellfina System | OUP | 2019-10-09 | 58 |
| K180623 | Ulthera System | OHV | 2018-05-04 | 56 |
| K161885 | The Cellfina System | OUP | 2016-10-05 | 86 |
| K153677 | The Cellfina System | OUP | 2016-02-25 | 66 |
| K150505 | Cellfina System | OUP | 2015-07-29 | 154 |
| K134032 | ULTHERA SYSTEM | OHV | 2014-06-20 | 171 |
3 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN080006 | De Novo | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 2009-09-11 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-11-14.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Ulthera, Inc. is the lead sponsor of 37 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03320096: Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis (Completed, started 2016-12-13)
- NCT03599349: Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences (Completed, started 2015-08-20)
- NCT02444169: Retrospective Evaluation of Combination Treatment With the Ulthera System (Completed, started 2015-04)
- NCT02416076: Ultherapy® for Treating the Face and Neck Using Standard Versus Simulines Transducers (Completed, started 2014-12-15)
- NCT02286804: Ultherapy for the Treatment of Spider Veins on the Legs (Completed, started 2014-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ulthera, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Ulthera, Inc.” (first 2012, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ulthera, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ulthera, Inc. is 86 days. Since 2017: 76 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ulthera, Inc.?
The most frequent FDA product codes under this applicant name are OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption, 10); OUP (Powered Surgical Instrument For Improvement In The Appearance Of Cellulite, 4).
Next steps
- See all 13 Ulthera, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OHV, Ulthera, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.