# K253878: LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Mar 4, 2026 after 90 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: 16 generations back to K943450 (1995). 105 ancestors in all.
No later device cites it as a predicate yet.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230720: LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001, Light Tree Ventures Europe B.V. (2023) Summary page 5.

## Indications for use
LUSTRE GoGlow Advanced LED Patches (Model: PR8001, PR9001) is an Over-the-Counter (OTC) device that emits energy in the blue and red spectrum for the treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K253878
Methodology: https://510kreport.com/methodology