Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)

The Radiant Renewal Skincare Wand is a handheld, rechargeable LED device for at-home skincare use. Models HD-44, HD-44A, HD-44B, HD-69, and HD-69A emit red and/or infrared and yellow light to treat full-face wrinkles, while models HD-44C and HD-69B emit blue light to treat mild to moderate inflammatory acne. The device operates for up to 5 minutes per treatment and is powered by a lithium-ion battery.

The subject device uses LED technology with wavelengths of 630±10nm (red), 830±10nm (infrared), 590±10nm (yellow), or 415±10nm (blue), depending on model. Irradiance ranges from 10–105 mW/cm² depending on wavelength and model. Battery capacity varies by model (30–130 mAh for subject device versus 55–95 mAh for predicate 1). Treatment time is 5 minutes per session. Housing materials include PC, ABS, silicon, and aluminum. The device includes firmware-controlled microprocessor operation with automatic 5-minute shutoff.

IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60601-2-57, IEC 62471, IEC 62133-2, IEC 62366-1, IEC 60601-1-6; ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 for biocompatibility; and FDA's Guidance for Software Device Functions.

The subject device is substantially equivalent because it uses identical LED technology and wavelengths, shares the same intended use (wrinkle reduction and acne treatment via light emission), operates under the same regulatory classification (Class II, 21 CFR 878.4810), and complies with the same voluntary standards as predicate devices K242700 and K223893. Although minor differences exist in battery capacity, irradiance levels, and housing materials, these fall within acceptable ranges and do not raise new safety or effectiveness concerns, as all variants meet identical electrical safety, biocompatibility, and photobiological safety standards.