FDA device listing
EnergyLounger,HigherDOSE Red Light Mat
FDA device listing 2071101670 · Shenzhen Kaiyan Medical Equipment Co., Ltd
Key facts
| Proprietary names | EnergyLounger,HigherDOSE Red Light Mat |
|---|---|
| Owner/operator | Shenzhen Kaiyan Medical Equipment Co., Ltd |
| Owner/operator number | 10049428 |
| Premarket submissions | K241947 |
| Product codes | ILY, OHS, OLI |
| Device names | ILY - Lamp, Infrared, Therapeutic Heating, OHS - Light Based Over The Counter Wrinkle Reduction, OLI - Fat Reducing Low Level Laser |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810, 878.5400, 890.5500 |
| Review panels | General & Plastic Surgery, Physical Medicine |
| Registered establishments | Shenzhen Kaiyan Medical Equipment Co., Ltd |
| Establishment registrations | 3011644607 |
| FEI numbers | 3011644607 |
| Establishment operations | Foreign Exporter, Manufacturer |
| 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