K-number	K253135
Device name	LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)
Applicant	Dongguan Yijiaming Technology Co., Ltd.
Product code	OHS
Device class	Class II
Decision date	Dec 23, 2025
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The LED Light Therapy Device is a home-use phototherapy mask and neck device that delivers red (660nm), near-infrared (850nm), and blue (415nm) light to treat full-face wrinkles and mild-to-moderate inflammatory acne. It features 74 LEDs with adjustable brightness levels and treatment durations of 10-20 minutes, powered by a 5V adapter for over-the-counter use.

Technological characteristics

The device uses 74 LEDs with 3-in-1 chip structure (660nm + 415nm + 850nm), delivering 40 mW/cm² for wrinkles and 25 mW/cm² for acne. It offers adjustable brightness (L1-L5) and three timing options. Compared to predicate Q-Rejuvalight Pro (80 LEDs with 605/630/660/880/415nm), the subject device uses consolidated wavelengths with similar power density and treatment area of 366.21 cm².

Test standards cited

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 60601-2-57, IEC 62471, IEC 62133-2, ISO 10993-5, ISO 10993-10, ISO 10993-23 for biocompatibility, electrical safety, electromagnetic compatibility, and photobiological safety.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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

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