510(k) K100702

STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS by Huot Instruments, LLC — Product Code FSY

K100702 is an FDA 510(k) premarket notification submitted by Huot Instruments, LLC for the device "STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS". The FDA issued a decision of Substantially Equivalent on July 20, 2010. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580.