Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

Lens, Contact (other Material) - Daily

Acuity Polymers, Inc.

The following data is part of a premarket notification filed by Acuity Polymers, Inc. with the FDA for Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens.

Pre-market Notification Details

Device IDK203571
510k NumberK203571
Device Name:Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
ClassificationLens, Contact (other Material) - Daily
Applicant Acuity Polymers, Inc. 1667 Lake Avenue, Suite 354 Rochester,  NY  14615
ContactJames A. Bonafini
CorrespondentBret Andre
EyeReg Consulting Inc. 6119 Canter Lane West Linn,  OR  97068
Product CodeHQD  
CFR Regulation Number886.5916 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-07
Decision Date2021-04-09

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