FDA device listing
Black Stellar XPL HP,Nd:YAG LightGuides,ResurFX™ Head,ResurFX™ Tips,Stellar M22™,Stellar M22™ accessory kit,Stellar M22™…
FDA device listing 1164854271 · Lumenis Be Ltd.
Key facts
| Proprietary names | Black Stellar XPL HP,Nd:YAG LightGuides,ResurFX™ Head,ResurFX™ Tips,Stellar M22™,Stellar M22™ accessory kit,Stellar M22™ Acne filter,Stellar M22™ AES IPL Module Kit,Stellar M22™ calibration filter,Stellar M22™ IPL filters,Stellar M22™ IPL handpiece,Stellar M22™ IPL LightGuides,Stellar M22™ Multi-Spot™ Nd:YAG Upgrade kit,Stellar M22™ Q-switched Nd:YAG upgrade kit,Stellar M22™ ResurFX™ Module… |
|---|---|
| Owner/operator | Lumenis Be Ltd. |
| Owner/operator number | 10082799 |
| Premarket submissions | K250809 |
| Product codes | GEX, ONF, ONG |
| Device names | GEX - Powered Laser Surgical Instrument, ONF - Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, ONG - Powered Laser Surgical Instrument With Microbeam\Fractional Output |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Lumenis Be Ltd |
| Establishment registrations | 3021349626 |
| FEI numbers | 3021349626 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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