Product areas
FDA product code distribution
510(k) submissions
Latest clearance
Product codes
FDA product code distribution
1 total · filtered by OHT
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K240016 | IPL Hair Removal Device (YT01,YT02,YT03,YT04) | OHT | Class 2 | 2024-07-10 |
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
Shenzhen Jianrong Biomedical Electronics Co., Ltd. references 3 predicate/reference devices
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)
Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)
IPL400
Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
4 submissions cite Shenzhen Jianrong Biomedical Electronics Co., Ltd. as a predicate