Cleared Traditional

IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)

K251176 · Shenzhen Mlay Intelligent Technology Co., Ltd. · General & Plastic Surgery

Aug 2025

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K251176 is an FDA 510(k) clearance for the IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C), 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 August 14, 2025, 120 days after receiving the submission on April 16, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K251176 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 16, 2025
Decision Date	August 14, 2025
Days to Decision	120 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.