FDA device listing
light therapy machine,Red light bed, model:C1, C2, C3, C4, C4N, C5, C6, C6N, C7, C-MB, C8, C9, C10, C10-1, C11, C12…
FDA device listing 1698722189 · Guangzhou Merican Optoelectronic Technology Co.,Ltd
Key facts
| Proprietary names | light therapy machine,Red light bed, model:C1, C2, C3, C4, C4N, C5, C6, C6N, C7, C-MB, C8, C9, C10, C10-1, C11, C12, C13, D3, D4, D10, D11,Red light bed,model:DA-1, DA-2, DA-3, DA-4, DA-5,DA-6,DA-7,DA-8,DA-9,DA-10,Red light bed,model:DH2-1, DH2-2, DH2-3, DH2-4,DH2-5,DH2-6, DH2-7,DH2-8,DH2-9,DH2-10,Red light bed,model:DH4-1, DH4-2, DH4-3, DH4-4, DH4-5, DH4-6, DH4-7, DH4-8,DH4-9,DH4-10,Red light… |
|---|---|
| Owner/operator | Guangzhou Merican Optoelectronic Technology Co.,Ltd |
| Owner/operator number | 10080752 |
| 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 | GUANGZHOU MERICAN OPTOELECTRONIC TECHNOLOGY CO.,LTD |
| Establishment registrations | 3015993373 |
| FEI numbers | 3015993373 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, 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