Cleared Traditional

K221002 - IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
(FDA 510(k) Clearance)

K221002 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery

Jun 2022

Decision

58d

Days

Class 2

Risk

K221002 is an FDA 510(k) clearance for the IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C, 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 June 1, 2022, 58 days after receiving the submission on April 4, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K221002 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2022
Decision Date	June 01, 2022
Days to Decision	58 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.