Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K252804Substantially Equivalent

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;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,

Shenzhen Ulike Smart Electronics Co.,Ltd, Shenzhen, CN / Special, Substantially Equivalent

K252804 is the FDA 510(k) clearance record for 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;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,, a class II device, cleared for Shenzhen Ulike Smart Electronics Co., Ltd. on under FDA product code OHT (Light Based Over-The-Counter Hair Removal). FDA's definition for product code OHT reads: "Over-the-counter device uses thermal energy to kill hair follicles for hair removal". FDA records list 23 510(k) clearances for Shenzhen Ulike Smart Electronics Co., Ltd., from to . As of , FDA records show no recalls naming K252804.

Clearance record

Decision date
Received
(28 days to decision)
Product code
OHT Light Based Over-The-Counter Hair Removal
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd. 810, Bldg. 1,Xunmei Science & Technology Plz.,#8 Keyuan Rd., Shenzhen, CN
510(k) summary
Statement
Third party review
No

Clearances, product code OHT

Trailing 12 months
14 clearances under product code OHT in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code OHT, trailing twelve months
MonthClearances
November 20253
December 20252
January 20260
February 20261
March 20261
April 20261
May 20263
June 20260
July 20260
August 20261
September 20262
October 20260