Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)— 510(k) K243430

Name: FDA 510(k) clearance K243430
Creator: U.S. Food and Drug Administration
Published: 2024-12-19

Substantially Equivalent

Shenzhen Aozemei Technology Co., Ltd.

FDA 510(k) clearance K243430 for Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W), Substantially Equivalent on 2024-12-19. Applicant: Shenzhen Aozemei Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Aozemei Technology Co., Ltd.
Product code: Code NFO
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2024-11-05
Decision date: 2024-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.