Manufacturer
Shenzhen Ulike Smart Electronics Co., Ltd.Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
Shenzhen Ulike Smart Electronics Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K250194
- Device name
- Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-01-23
- Decision date
- 2025-03-26
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsArmsOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. Applicable skin types: Fitzpatrick Skin Types I-V. Treatment area: Large areas (e.g. arms, legs, chest) and small areas (e.g. lip).
Intended Use
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Description
Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with a lamp that can emit continuously double or triple pulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
Summary parsed at:2026-06-11 04:27:52 UTC
Predicate devices
3IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
K250194 references 3 predicate/reference devices
Cited as predicate
3IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
3 submissions cite K250194 as a predicate
