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 |
|---|---|---|---|---|
| K173813 | IPL Hair Removal Device Joy Version | OHT | Class 2 | 2018-09-07 |
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)
Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
Home use hair removal device, model: Precise Touch Pro
9 submissions cite Shen Zhen Cosbeauty Co., Ltd. as a predicate