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510(k) K243430

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) by Shenzhen Aozemei Technology Co., Ltd. — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2024
Date Received
November 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Shenzhen Aozemei Technology Co., Ltd.

  • K241718 — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (October 28, 2024)

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  • K251909 — NeurotriS (SX2500); NeurotriS (SX3800) (September 3, 2025)
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