Tomey Cornea/Anterior Segment OCT CASIA2

Tomography, Optical Coherence

Tomey Corporation

The following data is part of a premarket notification filed by Tomey Corporation with the FDA for Tomey Cornea/anterior Segment Oct Casia2.

Pre-market Notification Details

Device IDK213265
510k NumberK213265
Device Name:Tomey Cornea/Anterior Segment OCT CASIA2
ClassificationTomography, Optical Coherence
Applicant Tomey Corporation 2-11-33 Noritakeshinmachi Nishi-ku,  JP 451-0051
ContactYuko Matsushita
CorrespondentRyan Bouchard
ORA, Inc. 300 Brickstone Square Andover,  MA  01801
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2022-04-27

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