Class Class II

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (K241718)

K241718 2024-10-28 Traditional
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Description

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) by Shenzhen Aozemei Technology Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241718
Clearance Date2024-10-28
Clearance TypeTraditional
Product CodeOHS
Regulation Number878.4810

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Predicate lineage for K241718

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (K241718) cites 2 predicate devices and is itself cited by 3 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K190443MMSphereGalactic Beauty, LLC2019
K1718212 Face / Face EvolutionHeat IN A Click2018

Later devices that cite this one as their predicate

Devices that cite K241718
K numberDeviceApplicantYear
K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C,...Shenzhen Lifotronic Technology Co.,...2025
K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment C...2025
K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technol...2025

Trace the full predicate network for K241718

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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