Device Name
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)Manufacturer
Date Cleared
2001-03-12
(55 days)
Product Code
Regulation Number
886.5925Type
TraditionalPanel
OphthalmicAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A