FDA device listing
Diode Laser Hair Removal System:AG108, AME50, OM101, OMG32, OMG121, OMG132, OMG134, OMG137, OMG138,,Multi-functional 980…
FDA device listing 1500230901 · GORGEOUS BEAUTY EQUIPMENT MANUFACTURE LIMITED
Key facts
| Proprietary names | Diode Laser Hair Removal System:AG108, AME50, OM101, OMG32, OMG121, OMG132, OMG134, OMG137, OMG138,,Multi-functional 980 1470 Diode Laser Machine:LLY006, LLY007, LLY008 ,LLY0030,LLY0043, OM213,OMG178, OMG179, OMG181, OMG214, OMG218, TMY001, TMY002, TMY003, TMY004, TMY005, TMY006, TMY007, TMY008, TMY009,,TMY010, TMY011, TMY012, TMY013, TMY014, TMY015, TMY016, TMY017, TMY018, TMY019, TMY020, TMY021… |
|---|---|
| Owner/operator | GORGEOUS BEAUTY EQUIPMENT MANUFACTURE LIMITED |
| Owner/operator number | 10094575 |
| Product codes | GEX |
| Device names | GEX - Powered Laser Surgical Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | GORGEOUS BEAUTY EQUIPMENT MANUFACTURE LIMITED |
| Establishment registrations | 3043012074 |
| FEI numbers | 3043012074 |
| Establishment operations | 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