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510(k) Data Aggregation
K Number
DEN250016Device Name
Essilor® Stellest®Manufacturer
Date Cleared
2025-09-25
(150 days)
Product Code
Regulation Number
886.5845Type
DirectPanel
OphthalmicReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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