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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K150878
Device Name ILUMIEN OPTIS
Applicant
Lightlab Imaging, Inc.
4 Robbins Rd.
Westford,  MA  01886
Applicant Contact ERDIE DE PERALTA
Correspondent
Lightlab Imaging, Inc.
4 Robbins Rd.
Westford,  MA  01886
Correspondent Contact ERDIE DE PERALTA
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received04/01/2015
Decision Date 07/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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