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FDA 510(k)

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

K-Number: K243430 · 2024-12-19

ApplicantShenzhen Aozemei Technology Co., Ltd.
Decision Date2024-12-19
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Aozemei Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K243430. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Shenzhen Aozemei Technology Co., Ltd.. The 510(k) number is K243430.

When did Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) receive FDA 510(k) clearance?

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K243430.

Who is the listed applicant for Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

The FDA 510(k) record lists Shenzhen Aozemei Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

The FDA product code for Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) is NFO.

Other records listing Shenzhen Aozemei Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)

Related Devices (Code: NFO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253932FACEGYM Pro Device (HD-109)Shenzhen Kaiyan Medical Equipment Co., Ltd.K260179VITA Multi-Function Head Brush (TB-2343F, TB-2442F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.K252621DeepSkin (DEP100)El Global Trade, Ltd.K252187Aura Glide (FC40)Aura Medical, LLCK252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)Shenzhen Siken 3D Technology Development Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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