FDA device listing
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001- RBMASK, FCM910)
FDA device listing 1323272708 · Shenzhen Fittop Health Technology Co., Ltd.
Key facts
| Proprietary names | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001- RBMASK, FCM910) |
|---|---|
| Owner/operator | Shenzhen Fittop Health Technology Co., Ltd. |
| Owner/operator number | 10060590 |
| Premarket submissions | K251588 |
| Product codes | ILY, OHS, OLP |
| Device names | ILY - Lamp, Infrared, Therapeutic Heating, OHS - Light Based Over The Counter Wrinkle Reduction, OLP - Over-The-Counter Powered Light Based Laser For Acne |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810, 890.5500 |
| Review panels | General & Plastic Surgery, Physical Medicine |
| Registered establishments | SHENZHEN FITTOP HEALTH TECHNOLOGY CO., LTD. |
| Establishment registrations | 3012657194 |
| FEI numbers | 3012657194 |
| Establishment operations | 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