Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200— 510(k) K221214

Name: FDA 510(k) clearance K221214
Creator: U.S. Food and Drug Administration
Published: 2022-09-21

Substantially Equivalent

Shenzhen Ionka Medical Technology Co., Ltd.

FDA 510(k) clearance K221214 for Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200, Substantially Equivalent on 2022-09-21. Applicant: Shenzhen Ionka Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Ionka Medical Technology Co., Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2022-04-27
Decision date: 2022-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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