FDA device listing
Red Light Therapy Device - RLAXX,Red Light Therapy Device - RLBXX,Red Light Therapy Device - RLCXX,Red Light Therapy…
FDA device listing 1571953866 · ATOP Lighting Co., Ltd.
Key facts
| Proprietary names | Red Light Therapy Device - RLAXX,Red Light Therapy Device - RLBXX,Red Light Therapy Device - RLCXX,Red Light Therapy Device - RLDXX,Red Light Therapy Device - RLFXX,Red Light Therapy Device - RLGXX,Red Light Therapy Device - RLlXX,Red Light Wand- SPE-RLW250J,SPE-RLW130J;SPE-RLW255J;SPE-RLW135J,SPE-RLWS130J |
|---|---|
| Owner/operator | ATOP Lighting Co., Ltd. |
| Owner/operator number | 10089135 |
| Product codes | ILY |
| Device names | ILY - Lamp, Infrared, Therapeutic Heating |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5500 |
| Review panels | Physical Medicine |
| Registered establishments | ATOP LIGHTING CO., LTD. |
| Establishment registrations | 3023371360 |
| FEI numbers | 3023371360 |
| 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