# K231894: LED Spectrum therapy instrument

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhenshi Sincoheren S&T Development Co., Ltd.
- Decided: Sep 20, 2023 after 84 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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). 149 ancestors in all.
No later device cites it as a predicate yet.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221083: Smartlux Mini, Medmix Co., Ltd. (2022) Summary page 7.
- K180900: LED Light Therapy Device, Uvbiotek, LLC (2018) Summary page 7.

## Indications for use
The LED Spectrum therapy instrument includes five models, which are PDT-I, PDT-J, PDT-K, PDT-L, PDT-M. PDT-I: Blue (420±10nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Combination of Red (630±10nm) and Blue (420±10nm) is indicated for the treatment of mild to moderate inflammatory acne. PDT-J: Combination of Yellow (590±10nm) and Infrared (825±10nm) is intended to emit energy in the IR and visible spectrum 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 where applied. Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. PDT-K: Blue (420±10nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Combination of Red (630±10nm) and Blue (420±10nm) is indicated for the treatment of mild to moderate inflammatory acne. PDT-L: Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. PDT-M: Combination of Yellow (590±10nm) and Infrared (825±10nm) is intended to emit energy in the IR and visible spectrum 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 where applied.

Source page: https://510kreport.com/device/K231894
Methodology: https://510kreport.com/methodology