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510(k) Data Aggregation
K Number
K242789Device Name
Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
Manufacturer
Date Cleared
2025-01-02
(108 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Laiguang Electronic Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device produces light in the blue light (415mm) is intended to reduce mild to moderate inflammatory acne vulgaris. The red light (635mm) in combination with near-infrared light (850mm) is intended to improve the appearance of wrinkles.
Device Description
The Bestqool LED therapy devices, available in models LMK-001, LMK-004, LMK-005, and LMK-006, differ only in their appearance color to cater to user preferences. The device is designed as a foldable arch shape and is equipped with 200 LED beads. Despite the color variations, the device structure and functional parameters remain identical across all models,which uses specific wavelengths of light to manage aesthetic conditions. This device does not come into contact with the body; users should lie under the device treatment area during use.The device is powered by an AC adapter. This device produces light in the blue light (415nm) is intended to reduce mild to moderate inflammatory acne vulgaris. The red light (635nm) in combination with near-infrared light (850nm) is intended to improve the appearance of wrinkles.
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