FDA device listing
Digital OptiLight Aesthetic™,IPL Upgrade Kit for OptiLight,OPT Handpiece,OptiLight™,OptiLight Accessories Kit,OptiLight…
FDA device listing 1061513085 · Lumenis Be Ltd.
Key facts
| Proprietary names | Digital OptiLight Aesthetic™,IPL Upgrade Kit for OptiLight,OPT Handpiece,OptiLight™,OptiLight Accessories Kit,OptiLight AES General Accessories Kit,OptiLight Aesthetic™,OptiLight Filter,OptiLight IPL Handpiece,OptiLight IPL Modality Filters Kits,OptiLight IPL Module Kit,Opti-Tip™,Opti-Tip Pack,OPT Module Kit,Stellar M22™ |
|---|---|
| Owner/operator | Lumenis Be Ltd. |
| Owner/operator number | 10082799 |
| Premarket submissions | DEN200028 |
| Product codes | QIU |
| Device names | QIU - Intense Pulsed Light Device For Managing Dry Eye |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.5201 |
| Review panels | Ophthalmic |
| 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
- 1–9 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