FDA 510(k) Application Details - K102266

Device Classification Name	Light, Surgical, Fiberoptic   More FDA Info for this Device
510(K) Number	K102266
Device Name	Light, Surgical, Fiberoptic
Applicant	ISOLUX LLC 1045 COLLIER CENTER WAY SUITE #6 NAPLES, FL 34110-8444 US Other 510(k) Applications for this Company
Contact	NIKOLAUS ANDREOULAKIS Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2010
Decision Date	09/24/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review