Product areas
FDA product code distribution
510(k) submissions
Latest clearance
Product codes
FDA product code distribution
4 total · filtered by OHT
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K253666 | IPL Hair Removal Device (Models: T31A, T32A) | OHT | Class 2 | 2026-02-23 |
| K251176 | IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) | OHT | Class 2 | 2025-08-14 |
| K241106 | Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) | OHT | Class 2 | 2024-05-22 |
| K240264 | Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) | OHT | Class 2 | 2024-03-08 |
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
IPL Hair Removal Device Joy Version
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)
Home use hair removal device
Shenzhen Mlay Intelligent Technology Co., Ltd. references 11 predicate/reference devices
IPL Hair Removal Device (Models: T31A, T32A)
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
4 submissions cite Shenzhen Mlay Intelligent Technology Co., Ltd. as a predicate