FDA device listing
Fringe Light Therapy Neck & Chest Mask (ZLD-50AK),LED Neck Beauty Mask,Project E Beauty Lumalux Face+ V2 3D LED Red…
FDA device listing 1415082802 · Shenzhen Kaiyan Medical Equipment Co., Ltd
Key facts
| Proprietary names | Fringe Light Therapy Neck & Chest Mask (ZLD-50AK),LED Neck Beauty Mask,Project E Beauty Lumalux Face+ V2 3D LED Red Light Therapy Face & Neck Mask(PE763),Project E Beauty Lumalux Face V2 3D LED Red Light Therapy Mask (PE762),Trudermal Glow Neck Decolletage & Hand |
|---|---|
| Owner/operator | Shenzhen Kaiyan Medical Equipment Co., Ltd |
| Owner/operator number | 10049428 |
| Premarket submissions | K254025 |
| Product codes | OHS, OLP |
| Device names | 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 |
| Review panels | General & Plastic Surgery |
| 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