IPL Hair Removal Device (Model: KCA423)— 510(k) K210119

Name: FDA 510(k) clearance K210119
Creator: U.S. Food and Drug Administration
Published: 2021-05-21

Substantially Equivalent

Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.

FDA 510(k) clearance K210119 for IPL Hair Removal Device (Model: KCA423), Substantially Equivalent on 2021-05-21. Applicant: Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2021-01-19
Decision date: 2021-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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