FDA device listing
imene Home Use Hair Removal Device (Model(s):T10A, T10D, T11A),KinseiBeauty Home Use Hair Removal Device (Model(s):T16A…
FDA device listing 1851088072 · Shenzhen Mlay Intelligent Technology Co.,Ltd.
Key facts
| Proprietary names | imene Home Use Hair Removal Device (Model(s):T10A, T10D, T11A),KinseiBeauty Home Use Hair Removal Device (Model(s):T16A, T17A),LuxDuo Home Use Hair Removal Device(Model: T11A),Mlay Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A),Wellfun Home Use Hair Removal Device (Model(s):T14A, T15A) |
|---|---|
| Owner/operator | Shenzhen Mlay Intelligent Technology Co.,Ltd. |
| Owner/operator number | 10089650 |
| Premarket submissions | K240264 |
| Product codes | OHT |
| Device names | OHT - Light Based Over-The-Counter Hair Removal |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Shenzhen Mlay Intelligent Technology Co., Ltd. |
| Establishment registrations | 3031182672 |
| FEI numbers | 3031182672 |
| 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