# K250194: Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Ulike Smart Electronics Co., Ltd.
- Decided: Mar 26, 2025 after 62 days
- Product code: OHT (Light Based Over-The-Counter Hair Removal)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K950019 (1995). 62 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242039: Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR), Shenzhen Ulike Smart Electronics Co., Ltd. (2024) Summary page 5.
- K230122: IPL Hair Removal Device, Model (s): UI04 SD, UI04 DG, Shenzhen Ulike Smart Electronics Co., Ltd. (2023) Summary page 5.
- K221002: IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C, Shenzhen Ulike Smart Electronics Co., Ltd. (2022) Summary page 5.

## Most influential descendants
- K261325: Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) (2026), 0 descendants of its own
- K251984: Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) (2025), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K250194
Methodology: https://510kreport.com/methodology