510(k) K093792

LED LIGHT SOURCE by Sunoptic Technologies, LLC — Product Code FCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2010
Date Received
December 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type