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

by Shenzhen Aozemei Technology Co., Ltd. 2 variants

510(k) K243430

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243430 Date19 Dec 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NFO
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Micro-current Facial Beauty Device is a transcutaneous electrical stimulator intended for aesthetic purposes, as defined by its device name and classification. It is substantially equivalent to a predicate device and has received FDA 510(k) clearance under product code NFO and regulation number 882.5890, with a neurology medical specialty designation.

The device is supplied as a reusable system comprising the models AM-810B, AM-810W, AM-812B, and AM-812W. It is manufactured by Shenzhen Aozemei Technology Co., Ltd. in Shenzhen, China, and is intended for use in clinical or professional settings for facial treatments. No sterility, single-use, MRI safety, size, or storage specifications are provided in the data.

Other devices from Shenzhen Aozemei Technology Co., Ltd.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Micro-current Facial Beauty Device intended for?

    The device is intended for aesthetic purposes as a transcutaneous electrical stimulator, specifically for facial treatments in clinical or professional settings, based on its classification and substantial equivalence to a predicate device.

  • How is the Micro-current Facial Beauty Device supplied and is it reusable?

    The device is supplied as a reusable system comprising the models AM-810B, AM-810W, AM-812B, and AM-812W, meaning it is designed for multiple uses after appropriate cleaning and maintenance between sessions.

  • What regulatory clearance does the Micro-current Facial Beauty Device have?

    The device has received FDA 510(k) clearance, indicating it is substantially equivalent to a legally marketed predicate device, under product code NFO and regulation number 882.5890.