# K253135: LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Yijiaming Technology Co., Ltd.
- Decided: Dec 23, 2025 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: 20 generations back to K943450 (1995). 205 ancestors in all.
No later device cites it as a predicate yet.
0 of 206 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230042: Q-Rejuvalight Pro Facewear (Model: P19-0023), Light Tree Ventures Europe B.V. (2023) Summary page 6.
- 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), Shenzhen Zhenxing Ruitong Technology Co., Ltd. (2025). Cleared while this submission was under review Summary page 6.

## Indications for use
For model:HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HGMZ-2W-G1V1,HGMZ-2W-G2V1 The LED LIGHT THERAPY MASK is an Over-the-Counter (OTC) light based device Red light: Treatment of full- face wrinkles (only model HHGMZ-2W-G1V1, HGMZ-2W-G2V1). Blue light: Treatment of mild to moderate inflammatory acne. (only suitable model HLGMZ-3W-G1V1 and HLGMZ-3W-G2V1) Mixed light(Red+NIR light): Treatment of full face wrinkles (Model: HLGMZ-3W-G1V1, HLGMZ-3W-G2V1) For model:HLG-GJXJ-G1V1,MRD-GJXJ-G1V1 The Led Light Therapy for Neck is an Over-the-Counter (OTC) light based device Red light: Treatment of neck wrinkles (Model: MRD-GJXJ-G1V1) Mixed light(Red+NIR light): Treatment of neck wrinkles (Model: HLG-GJXJ-G1V1)

Source page: https://510kreport.com/device/K253135
Methodology: https://510kreport.com/methodology