# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Jianchao Intelligent Technology Co., Ltd.
- Decided: Jan 30, 2026 after 60 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: 20 generations back to K943450 (1995). 184 ancestors in all.
No later device cites it as a predicate yet.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241718: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W), Shenzhen Aozemei Technology Co., Ltd. (2024) Summary page 5.
- K171821: 2 Face / Face Evolution, Heat IN A Click (2018) Summary page 5.
- K210545: Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Marci Beauty, Inc. (2022) Summary page 5.

## Indications for use
Model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808: Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes. (1) The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation. (2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. Model: INIA-ED001, INIA-ED002, INIA-BLD001, E1507: Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes. (1) The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation; (2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K253833
Methodology: https://510kreport.com/methodology