FDA device listing
HIFEM Beauty System
FDA device listing 1427866908 · BEIJING WINKONLASER TECHNOLOGY LIMITED
Key facts
| Proprietary names | HIFEM Beauty System |
|---|---|
| Owner/operator | BEIJING WINKONLASER TECHNOLOGY LIMITED |
| Owner/operator number | 10086148 |
| Product codes | OUP |
| Device names | OUP - Powered Surgical Instrument For Improvement In The Appearance Of Cellulite |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4790 |
| Review panels | General & Plastic Surgery |
| Registered establishments | BEIJING WINKONLASER TECHNOLOGY LIMITED |
| Establishment registrations | 3015452693 |
| FEI numbers | 3015452693 |
| Establishment operations | Foreign Private Label Distributor, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database