NTN · Class II · 21 CFR 876.1500

FDA Product Code NTN: Led Light Source

Used To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals

Leading manufacturers include Olympus Winter & Ibe GmbH, Schoelly Imaging, Inc. and Optim, Inc..

9
Total
9
Cleared
111d
Avg days
2009
Since

FDA 510(k) Cleared Led Light Source Devices (Product Code NTN)

9 devices
1–9 of 9
Cleared Mar 16, 2015
ARTEMIS LIGHT ENGINE
K141164
Quest Medical Imaging
Gastroenterology & Urology · 315d
Cleared Jul 30, 2014
ENDOLED
K133311
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 275d
Cleared Jun 19, 2013
CLL- V1 LIGHT SOURCE
K130819
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 86d
Cleared Dec 14, 2012
VIDEO SYSTEM CENTER
K122831
Olympus Medical Systems Corp.
Gastroenterology & Urology · 88d
Cleared Jan 12, 2012
LUCEA LED SURGICAL LIGHT SYSTEM
K113679
Maquet S.A.S.
Gastroenterology & Urology · 29d
Cleared Mar 22, 2011
SOPRO 281
K103813
Sopro
Gastroenterology & Urology · 83d
Cleared Aug 17, 2010
LO-50 LED LIGHT SOURCE
K102167
Fiberoptics Technology, Inc.
Gastroenterology & Urology · 15d
Cleared Jul 28, 2009
PLS PORTABLE LIGHT SOURCE
K091829
Optim, Inc.
Gastroenterology & Urology · 39d
Cleared May 11, 2009
FSC 2
K090601
Schoelly Imaging, Inc.
Gastroenterology & Urology · 67d

About Product Code NTN - Regulatory Context