# K253874: LED Therapy Light (COB1400, HP1800PRO)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Hanhua Opto Co., Ltd.
- Decided: Mar 3, 2026 after 89 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: 17 generations back to K943450 (1995). 177 ancestors in all.
No later device cites it as a predicate yet.
0 of 178 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 6.
- K212275: Dermalux Flex MD, Aesthetic Technology, Ltd. (2021) Summary page 6.
- K171323: Biophotas CELLUMA3, Biophotas, Inc. (2017) Summary page 6.

## Indications for use
The LED Therapy Light is an over-the-counter (OTC) device intended for the following uses: For Red Mode: The device emits energy in the red spectrum and is intended for the treatment of full-face wrinkles. For NIR Mode: The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. For Red + NIR Mode: The device emits energy in the red and infrared spectrum and is intended for the treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K253874
Methodology: https://510kreport.com/methodology