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510(k) K102167

Device
LO-50 LED LIGHT SOURCE
Applicant
FIBEROPTICS TECHNOLOGY, INC.
510(k) number
K102167
Product code
NTN  
Decision
Substantially Equivalent (SESE)
Decision date
2010-08-17
Date received
2010-08-02
Regulation
876.1500
Classification name
Led Light Source
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
ALLAN GUILLOTTE
Address
1 Quassett Rd. Pomfret CT US 06258 06258

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NTN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141164ARTEMIS LIGHT ENGINEQuest Medical Imaging2015-03-16
K133311ENDOLEDOlympus Winter & Ibe GmbH2014-07-30
K130819CLL- V1 LIGHT SOURCEOlympus Winter & Ibe GmbH2013-06-19
K122831VIDEO SYSTEM CENTEROlympus Medical Systems Corp.2012-12-14
K113679LUCEA LED SURGICAL LIGHT SYSTEMMaquet S.A.S.2012-01-12
K103813SOPRO 281Sopro2011-03-22
K091829PLS PORTABLE LIGHT SOURCEOptim, Inc.2009-07-28
K090601FSC 2Schoelly Imaging, Inc.2009-05-11

Legacy Summary#

summary

FDA Review#

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