510(k) K152461

The Time Machine Series Lasers by Medical Lasers Manufacturer, Inc. — Product Code ILY

K152461 is an FDA 510(k) premarket notification submitted by Medical Lasers Manufacturer, Inc. for the device "The Time Machine Series Lasers". The FDA issued a decision of Substantially Equivalent on July 8, 2016. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500.