510(k) K142078

VELASII THERAPY LASER SYSTEM by Aspen Laser Systems, LLC — Product Code ILY

K142078 is an FDA 510(k) premarket notification submitted by Aspen Laser Systems, LLC for the device "VELASII THERAPY LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on October 30, 2014. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Aspen Laser Systems, LLC has at least 1 other 510(k) clearance on record.