510(k) K244022

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) by Boston Aesthetics, Inc. — Product Code FTC

K244022 is an FDA 510(k) premarket notification submitted by Boston Aesthetics, Inc. for the device "308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)". The FDA issued a decision of Substantially Equivalent on March 13, 2025. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Boston Aesthetics, Inc. has at least 5 other 510(k) clearances on record.