# K252264: MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Zhenxing Ruitong Technology Co., Ltd.
- Decided: Oct 17, 2025 after 88 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: 19 generations back to K943450 (1995). 186 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230351: LED Facial Mask, Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. (2023) Summary page 5.
- K242385: LED Therapy Mask (MN1, M226), Shenzhen Borria Technology Co., Ltd. (2025) Summary page 6.

## Most influential descendants
- K261851: LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) (2026), 0 descendants of its own
- K253135: LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) (2025), 0 descendants of its own

## Indications for use
The MEGELIN LED Light Therapy Mask is an Over-the-Counter (OTC) light based device. ● Red light: Treatment of full-face wrinkles. ● Blue light (only suitable model JML1, JML3, JML5, JML6, JML9 Face mask): Treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K252264
Methodology: https://510kreport.com/methodology