# K243555: LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Eyco Technology Co., Ltd.
- Decided: Feb 5, 2025 after 79 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: 17 generations back to K943450 (1995). 182 ancestors in all.
No later device cites it as a predicate yet.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223544: LED light therapy mask (FM-01, FM-02, FM-03), Guangdong Newdermo Biotech Co., Ltd. (2023) 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 6.

## Indications for use
- Mode 1 (Red + Infrared light): treatment of full face wrinkles. - Mode 2 (Blue light): Treatment of mild to moderate inflammatory acne. - Mode 3 (Mixed light): Treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K243555
Methodology: https://510kreport.com/methodology