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,
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 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 3 |
| December 2025 | 2 |
| January 2026 | 0 |
| February 2026 | 1 |
| March 2026 | 1 |
| April 2026 | 1 |
| May 2026 | 3 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 1 |
| September 2026 | 2 |
| October 2026 | 0 |
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