Medical Device Manufacturer · CN , Shenzhen

Shenzhen Mlay Intelligent Technology Co., Ltd.

4 submissions · 4 cleared · Since 2024

Total

Cleared

Denied

Shenzhen Mlay Intelligent Technology Co., Ltd. — FDA 510(k) Submissions

Shenzhen Mlay Intelligent Technology Co., Ltd. has submitted 4 FDA 510(k) premarket notifications since 2024, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Light Based Over-the-counter Hair Removal . Use the specialty filter in the sidebar to narrow results.

4 devices

1–4 of 4

IPL Hair Removal Device (Models: T31A, T32A)

K253666 · OHT Light Based... · General & Plastic Surgery

Feb 2026 94d

IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)

K251176 · OHT Light Based... · General & Plastic Surgery

Aug 2025 120d

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)

K241106 · OHT Light Based... · General & Plastic Surgery

May 2024 30d

Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)