NTN — Led Light Source Class II

FDA Device Classification

Classification Details

Product Code
NTN
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K141164quest medical imagingARTEMIS LIGHT ENGINEMarch 16, 2015
K133311olympus winter and ibeENDOLEDJuly 30, 2014
K130819olympus winter and ibeCLL- V1 LIGHT SOURCEJune 19, 2013
K122831olympus medical systemsVIDEO SYSTEM CENTERDecember 14, 2012
K113679maquetLUCEA LED SURGICAL LIGHT SYSTEMJanuary 12, 2012
K103813soproSOPRO 281March 22, 2011
K102167fiberoptics technologyLO-50 LED LIGHT SOURCEAugust 17, 2010
K091829optimPLS PORTABLE LIGHT SOURCEJuly 28, 2009
K090601schoelly imagingFSC 2May 11, 2009