Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)

The Radiant Renewal Skincare Lid is a light-based over-the-counter cosmetic device with multiple models designed to treat wrinkles and/or mild to moderate inflammatory acne. Different models use red light, blue light, infrared light, or combinations thereof to deliver therapeutic light energy to facial skin. The device is battery-powered and intended for home use.

The device uses LED and laser light sources emitting wavelengths in the red (590–700 nm), blue (415–495 nm), yellow (580–630 nm), and infrared (800–1100 nm) ranges. It is powered by rechargeable lithium-ion batteries and housed in materials including PC, PP, stainless steel, ABS, silicon, and aluminum. Multiple models offer different treatment modes and treatment times ranging from 2 to 5 minutes, with irradiances and fluences specified for each light type.

IEC 60601-1-11 (home healthcare electrical safety), IEC 60601-2-57 (light source equipment safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 62471 (photobiological safety), IEC 62133-2 (lithium battery safety), ISO 10993-1/5/10/23 (biocompatibility), IEC 62366-1 (usability engineering), and IEC 60601-1-6 (collateral usability standard).

The subject device uses substantially similar LED and laser light technology, indications (wrinkles and acne treatment), and over-the-counter cosmetic use pathway as five predicate devices (K230293, K240089, K241718, K241857, K203271). All devices employ photobiomodulation at comparable wavelengths and irradiances with similar battery-powered, handheld or wearable form factors. Performance testing demonstrating electrical safety, biocompatibility, software validation, and usability supports that the proposed device performs substantially similarly to the predicates without raising new safety or effectiveness concerns for the stated indications.