OPTIS Integrated System Mobile Workstation

System, Imaging, Optical Coherence Tomography (oct)

LIGHTLAB IMAGING, INC.

The following data is part of a premarket notification filed by Lightlab Imaging, Inc. with the FDA for Optis Integrated System Mobile Workstation.

Pre-market Notification Details

Device IDK151286
510k NumberK151286
Device Name:OPTIS Integrated System Mobile Workstation
ClassificationSystem, Imaging, Optical Coherence Tomography (oct)
Applicant LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD Westford,  MA  01886
ContactPadmini Suravaram
CorrespondentErdie De Peralta
LIGHTLAB IMAGING,INC. 4 ROBBINS ROAD Westford,  MA  01866
Product CodeNQQ  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-14
Decision Date2015-08-05
Summary:summary

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