Visionary Optics Scleral Contact Lens (roflufocon D, Roflufocon E, Hexafocon A, Hexafocon B, Tisilfocon A)

Lens, Contact (other Material) - Daily

Visionary Optics LLC

The following data is part of a premarket notification filed by Visionary Optics Llc with the FDA for Visionary Optics Scleral Contact Lens (roflufocon D, Roflufocon E, Hexafocon A, Hexafocon B, Tisilfocon A).

Pre-market Notification Details

Device IDK223394
510k NumberK223394
Device Name:Visionary Optics Scleral Contact Lens (roflufocon D, Roflufocon E, Hexafocon A, Hexafocon B, Tisilfocon A)
ClassificationLens, Contact (other Material) - Daily
Applicant Visionary Optics LLC 1325 Progress Drive Front Royal,  VA  22630
ContactDonald R. Sanders
CorrespondentBret Andre
EyeReg Consulting Inc. 6119 Canter Lane West Linn,  OR  97068
Product CodeHQD  
CFR Regulation Number886.5916 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-11-08
Decision Date2022-12-07

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