Cleared Special

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)

K241106 · Shenzhen Mlay Intelligent Technology Co., Ltd. · General & Plastic Surgery

May 2024

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K241106 is an FDA 510(k) clearance for the Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A), a Light Based Over-the-counter Hair Removal (Class II — Special Controls, product code OHT), submitted by Shenzhen Mlay Intelligent Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 22, 2024, 30 days after receiving the submission on April 22, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K241106 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2024
Decision Date	May 22, 2024
Days to Decision	30 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.