ILUMIEN OPTIS

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 Ilumien Optis.

Pre-market Notification Details

Device IDK123369
510k NumberK123369
Device Name:ILUMIEN OPTIS
ClassificationSystem, Imaging, Optical Coherence Tomography (oct)
Applicant LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD Westford,  MA  01886
ContactJeffrey Roberts
CorrespondentJeffrey Roberts
LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD Westford,  MA  01886
Product CodeNQQ  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-01
Decision Date2013-01-30
Summary:summary

Trademark Results [ILUMIEN OPTIS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ILUMIEN OPTIS
ILUMIEN OPTIS
86060599 4577531 Live/Registered
LightLab Imaging, Inc.
2013-09-10
ILUMIEN OPTIS
ILUMIEN OPTIS
85763120 4576575 Live/Registered
LightLab Imaging, Inc.
2012-10-25

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