Cleared Traditional

IPL Hair Removal Device, Model(s): UI04?SD, UI04?DG

K230122 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery
Apr 2023
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K230122 is an FDA 510(k) clearance for the IPL Hair Removal Device, Model(s): UI04?SD, UI04?DG, 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 10, 2023, 83 days after receiving the submission on January 17, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number K230122 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2023
Decision Date April 10, 2023
Days to Decision 83 days
Submission Type Traditional
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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