# K162098: LED Phototherapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Li-Tek Electronic Technology Corporation
- Decided: Jan 30, 2017 after 185 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: 13 generations back to K943450 (1995). 148 ancestors in all.
75 later devices descend from it; 5 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121435: Silkn Blue, Home Skinovations, Ltd. (2013) Summary page 4.
- K111286: Quasar Calypso, Silver Bay, LLC (2012) Summary page 4.
- K141308: Nutra Light Red, Nutra Luxe MD, LLC (2014) Summary page 4.

## Most influential descendants
- K171821: 2 Face / Face Evolution (2018), 58 descendants of its own
- K192295: PDT-Face (2020), 46 descendants of its own
- K212155: TheraFace LED (2021), 42 descendants of its own
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), 39 descendants of its own
- K202390: Aduro Light Beauty Mask (2021), 39 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.

Source page: https://510kreport.com/device/K162098
Methodology: https://510kreport.com/methodology