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510(k) K080788

VIVASCOPE SYSTEM, MODEL 1500, 3000 by Lucid, Inc. — Product Code PSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2008
Date Received
March 20, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Imaging
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Emission and collection of light to create an image for medical purposes

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