Data / Medical devices / Skin Resurfacing Rf Applicator
Skin Resurfacing Rf Applicator (OUH): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Skin Resurfacing Rf Applicator (product code OUH, Class 2, 21 CFR 878.4400). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on January 15, 2016, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OUH
- Device class
- 2
- Regulation
- 878.4400
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| Israel | 2 |
| South Korea | 2 |
| United States | 2 |
| China | 2 |
| Singapore | 1 |
Makers of Skin Resurfacing Rf Applicator
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Endymed Medical Ltd | Caesarea Northern, Israel | Manufacturer | 3 | March 13, 2014 | 0 | 0 | 0 | api.fda.gov |
| Jeisys Medical Inc. | Seoul, South Korea | Manufacturer | 1 | June 4, 2015 | 0 | 0 | 0 | api.fda.gov |
| Aesthetics Biomedical Inc. | Phoenix, AZ, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Beijing Syntech Laser Co., Ltd. | Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classys Inc | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Fuqiang Beauty Equipment Co.,limited | Qingyuan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I. Sherman | Acre Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rohrer Aesthetics, Inc. | Homewood, AL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smicna Pte Ltd | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 15, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.