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

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Aozemei Technology Co., Ltd.
- Decided: Oct 28, 2024 after 136 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 172 ancestors in all.
12 later devices descend from it; 7 cite it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171821: 2 Face / Face Evolution, Heat IN A Click (2018) Summary page 5.
- K190443: MMSphere, Galactic Beauty, LLC (2019) Summary page 5.
- K230351: LED Facial Mask, Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (2024), 6 descendants of its own
- K250761: KALA Therapy Wand (Model: KALA-03) (2025), 1 descendant of its own
- K251042: Light Therapy System (M500, L6) (2025), 1 descendant of its own
- K242151: Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) (2025), 1 descendant of its own
- K253833: Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) (2026), 0 descendants of its own

## Indications for use
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K241718
Methodology: https://510kreport.com/methodology