Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)

The Bestqool LED Therapy Device (models LMK-001, LMK-004, LMK-005, LMK-006) is a foldable arch-shaped device with 200 LED beads that emits specific wavelengths of light for aesthetic treatment. Blue light (415 nm) is intended to reduce mild to moderate inflammatory acne vulgaris, while red (635 nm) and near-infrared (850 nm) light in combination are intended to improve the appearance of wrinkles. The device does not contact the body; users lie under the treatment area during use.

The subject device has identical structure and functional parameters across all four color variants. It operates at input 100–240 Vac, 0.6 A, 50/60 Hz with wavelengths of 415±10 nm (blue), 635±10 nm (red), and 850±10 nm (near-infrared). Irradiance is 7.5 mW/cm² ± 25%, treatment dose is 13.5 J/cm² ± 25%, and recommended use is 4 times per week for 30–60 minutes over 4 weeks. These parameters are comparable to the predicate device (465, 640, 880 nm; 6.5 mW/cm²; 11.7 J/cm²).

IEC 60601-1:2005+A1:2012+A2:2020 (medical electrical equipment general safety), IEC 60601-1-11:2015+A1:2020 (home healthcare), IEC 60601-1-2:2014+A1:2020 (EMC), IEC 60601-1-6:2010 with amendments (usability), IEC 60601-2-57:2011 (non-laser light source equipment for therapeutic/cosmetic use), and IEC 62471:2006 (photobiological safety). Software validation followed 2023 FDA guidance on device software functions.

The device has the same indications for use, regulatory classification, product codes (OHS, OLP), and working principle as the predicate K200983. Wavelengths, irradiance, and treatment dose are substantially similar with only minor differences in absolute values. Performance testing confirmed wavelength, irradiance, and dose delivery meet specifications. Because the subject device does not raise new safety or efficacy questions and demonstrates equivalent technological characteristics and intended use, it is substantially equivalent to the predicate device.