Cleared Special

Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)

K253881 · Shenzhen Fansizhe Science And Technology Co., Ltd. · General & Plastic Surgery

Dec 2025

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K253881 is an FDA 510(k) clearance for the Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM), a Light Based Over-the-counter Hair Removal (Class II — Special Controls, product code OHT), submitted by Shenzhen Fansizhe Science And Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 29, 2025, 25 days after receiving the submission on December 4, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K253881 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2025
Decision Date	December 29, 2025
Days to Decision	25 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.