Acuity 200 With Tangible Hydra-PEG (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 With Tangible Hydra-peg (fluoroxyfocon A) Rigid Gas Permeable Contact Lens.

Pre-market Notification Details

Device IDK213538
510k NumberK213538
Device Name:Acuity 200 With Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
ClassificationLens, Contact (other Material) - Daily
Applicant Acuity Polymers, Inc. 1667 Lake Ave. Suite 303 Rochester,  NY  14615
ContactJames A Bonafini
CorrespondentJames A Bonafini
Acuity Polymers, Inc. 1667 Lake Ave. Suite 303 Rochester,  NY  14615
Product CodeHQD  
CFR Regulation Number886.5916 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-08
Decision Date2021-12-30

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