Cleared Special

Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K

K221569 · Shenzhen Fansizhe Science And Technology Co., Ltd. · General & Plastic Surgery
Jun 2022
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K221569 is an FDA 510(k) clearance for the Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K, 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 June 30, 2022, 30 days after receiving the submission on May 31, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number K221569 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2022
Decision Date June 30, 2022
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.

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