FDA product code OUH: Skin Resurfacing Rf Applicator
OUH is the FDA product code for skin resurfacing rf applicator. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under OUH, from 3 different applicants. The average 510(k) review took 259 days (median 261). FDA has posted 1 recall for OUH devices.
Definition
Skin resurfacing
Classification
| Field | Value |
|---|---|
| Device name | Skin Resurfacing Rf Applicator |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OUH clearance
Top OUH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Endymed Medical, Ltd. | 3 | 2014-03-13 |
| Sung Hwan E&B Co.,Ltd | 1 | 2016-01-15 |
| Jeisys Medical, Inc. | 1 | 2015-06-04 |
Most recent OUH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150409 | Sung Hwan E&B Co.,Ltd | VIVACE Electrosurgical System | 2016-01-15 | 331 |
| K142833 | Jeisys Medical, Inc. | INTRAGen | 2015-06-04 | 247 |
| K130501 | Endymed Medical, Ltd. | INTENSIF | 2014-03-13 | 379 |
| K120513 | Endymed Medical, Ltd. | GLOW BY ENDYMED | 2012-05-08 | 77 |
| K101510 | Endymed Medical, Ltd. | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | 2011-02-17 | 261 |
Recalls for OUH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-03-13.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code OUH?
OUH is the FDA product code for skin resurfacing rf applicator. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is OUH?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUH?
Across 5 cleared submissions the average was 259 days from receipt to decision (median 261).
Which companies have the most OUH clearances?
Endymed Medical, Ltd. (3); Sung Hwan E&B Co.,Ltd (1); Jeisys Medical, Inc. (1).
Have OUH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-03-13.
Next steps
- Run an FDA pathway report with predicate devices for product code OUH
- Run a recall and safety report across every OUH manufacturer
- Watch product code OUH 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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