Device Name
OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)Manufacturer
Date Cleared
1996-01-03
(233 days)
Product Code
Regulation Number
886.5916Type
TraditionalPanel
OphthalmicAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A