Data / Medical devices / Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite (OUP): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Powered Surgical Instrument For Improvement In The Appearance Of Cellulite (product code OUP, Class 2, 21 CFR 878.4790). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on August 18, 2023, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OUP
- Device class
- 2
- Regulation
- 878.4790
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| Hong Kong | 4 |
| United States | 1 |
| Costa Rica | 1 |
Makers of Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
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 |
|---|---|---|---|---|---|---|---|---|
| Tiger Aesthetics Medical-SD | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | August 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Beijing Beautemax Technology Limited | Beijing, China | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Perfectlaser Technology Co.,ltd | Beijing, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Winkonlaser Technology Limited | Beijing, China | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Alajuela | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gorgeous Beauty Equipment Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Biotechnology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Technology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Tuosite Technology Co.,ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oman Medical Beauty Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanhe Jumei Technology Co.,ltd | Sanhe Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 18, 2023. 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.