# K192295: PDT-Face

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Adss Development Co., Ltd.
- Decided: May 1, 2020 after 252 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- 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: 14 generations back to K943450 (1995). 151 ancestors in all.
46 later devices descend from it; 3 cite it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162098: LED Phototherapy Device, Li-Tek Electronic Technology Corporation (2017) Summary page 6.
- K172555: Sapphire, Elevare Sapphire, Omm Imports, Inc. D/B/A Zero Gravity (2018) Summary page 6.

## Most influential descendants
- K202390: Aduro Light Beauty Mask (2021), 39 descendants of its own
- K220168: Skin Care Beauty Mask (Model: MJ-06) (2022), 34 descendants of its own
- K230351: LED Facial Mask (2023), 33 descendants of its own
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own
- K230293: TheraFace Mask (2023), 16 descendants of its own

## Indications for use
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. The device is indicated for adults only.

Source page: https://510kreport.com/device/K192295
Methodology: https://510kreport.com/methodology