# K162489: RED Light Device

- Pathway: 510(k) (Traditional)
- Applicant: Zhongshan Bisen Plastic Electronic Products Co., Ltd.
- Decided: Jan 13, 2017 after 128 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: 13 generations back to K943450 (1995). 93 ancestors in all.
55 later devices descend from it; 5 cite it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152332: Perfectio LED infrared device, Omm Imports Inc Dba Zero Gravity (2016) Summary page 6.

## Most influential descendants
- 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
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own
- 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
- K241102: Luna 4 plus (2024), 5 descendants of its own

## Indications for use
The RED Light Device is an OTC device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K162489
Methodology: https://510kreport.com/methodology