FDA product code OUP: Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
OUP is the FDA product code for powered surgical instrument for improvement in the appearance of cellulite. It is a Class II device, regulated under 21 CFR 878.4790 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under OUP, 2 in the last five years, from 4 different applicants. The average 510(k) review took 84 days (median 84). 1 De Novo request was granted under it. FDA has posted 1 recall for OUP devices.
Definition
Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
Classification
| Field | Value |
|---|---|
| Device name | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite |
| Device class | Class II |
| Regulation | 21 CFR 878.4790 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for OUP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 58 |
| 2021 | 1 | 81 |
| 2022 | 1 | 88 |
| 2023 | 1 | 30 |
Compare with all 510(k) review times · Search every OUP clearance
Top OUP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ulthera, Inc. | 4 | 2019-10-09 |
| Revelle Aesthetics, Inc. | 2 | 2023-08-18 |
| Nc8, Inc. | 1 | 2021-10-22 |
| Cabochon Aesthetics, Inc. | 1 | 2014-04-14 |
Most recent OUP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232153 | Revelle Aesthetics, Inc. | Avéli | 2023-08-18 | 30 |
| K221336 | Revelle Aesthetics, Inc. | Avéli | 2022-08-05 | 88 |
| K212399 | Nc8, Inc. | Aveli | 2021-10-22 | 81 |
| K192185 | Ulthera, Inc. | The Cellfina System | 2019-10-09 | 58 |
| K161885 | Ulthera, Inc. | The Cellfina System | 2016-10-05 | 86 |
Recalls for OUP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-11-14.
Frequently asked questions
What is FDA product code OUP?
OUP is the FDA product code for powered surgical instrument for improvement in the appearance of cellulite. It is a Class II device, regulated under 21 CFR 878.4790 and reviewed by the General and Plastic Surgery panel.
What device class is OUP?
Class II, regulation 21 CFR 878.4790. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUP?
Across 8 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most OUP clearances?
Ulthera, Inc. (4); Revelle Aesthetics, Inc. (2); Nc8, Inc. (1); Cabochon Aesthetics, Inc. (1).
Have OUP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-11-14.
Next steps
- Run an FDA pathway report with predicate devices for product code OUP
- Run a recall and safety report across every OUP manufacturer
- Watch product code OUP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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