Cleared Special

Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

K251984 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery
Jul 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K251984 is an FDA 510(k) clearance for the Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU), 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 July 24, 2025, 27 days after receiving the submission on June 27, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number K251984 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2025
Decision Date July 24, 2025
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

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.

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