Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head

Confocal Optical Imaging

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Visera Elite Ii Xenon Light Source, Telescope Ir/telescope Ultra, Visera Elite Ii Video System Center, Hd 3cmos Autoclavable Camera Head, Hd 3cmos Camera Head.

Pre-market Notification Details

Device IDK200542
510k NumberK200542
Device Name:Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
ClassificationConfocal Optical Imaging
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentLisa M. Boyle
Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodeOWN  
Subsequent Product CodeFET
Subsequent Product CodeGCJ
Subsequent Product CodeHET
Subsequent Product CodeNWB
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2020-03-03
Decision Date2020-07-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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