Cleared Special

Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)

K240652 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery
Apr 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K240652 is an FDA 510(k) clearance for the Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR), 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 April 4, 2024, 28 days after receiving the submission on March 7, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number K240652 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2024
Decision Date April 04, 2024
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.

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