Cleared Special

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 (FDA 510(k) Clearance)

Also includes:

UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL,

K252804 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery device

Oct 2025

Decision

28d

Days

Class 2

Risk

K252804 is an FDA 510(k) clearance for the 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. This device is classified as a Light Based Over-the-counter Hair Removal (Class II - Special Controls, product code OHT).

Submitted by Shenzhen Ulike Smart Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 1, 2025, 28 days after receiving the submission on September 3, 2025.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal..

Submission Details

510(k) Number	K252804 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 03, 2025
Decision Date	October 01, 2025
Days to Decision	28 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	OHT — Light Based Over-the-counter Hair Removal
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal.