Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)— 510(k) K261325
Substantially EquivalentShenzhen Ulike Smart Electronics Co., Ltd.
FDA 510(k) clearance K261325 for Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU), Substantially Equivalent on 2026-05-21. Applicant: Shenzhen Ulike Smart Electronics Co., Ltd.. Device class: 2.
Summary
Shenzhen Ulike Smart Electronics' Ice Cooling IPL Hair Removal Device is listed with six model numbers (UI06S PR, PN, WH, PRU, PNU and WHU). It's filed under OHT, light based over-the-counter hair removal.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel, and the submission was a Special 510(k).
Ulike filed from Shenzhen, China. Review took 29 calendar days (April 22 to May 21, 2026).
Clearance details
- Applicant
- Shenzhen Ulike Smart Electronics Co., Ltd.
- Product code
- Product code OHT
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Shenzhen, CN
Recent devices under product code OHT
view all- K262352 — IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)
- K261975 — Braun Aura 7 (6041)
- K261977 — Braun Aura 9 (6042)
- K262524 — Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
More clearances from Shenzhen Ulike Smart Electronics Co., Ltd.
view all- K260742 — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
- K260511 — Ulike Reglow Light Therapy Device (UM10)
- K251825 — Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
- K252804 — Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG +4 more
- K251984 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
Data sourced from openFDA. This site is unofficial and independent of the FDA.