Custom Stable Rigid Gas Permeable Scleral Contact Lens

Lens, Contact (other Material) - Daily

Valley Contax, Inc.

The following data is part of a premarket notification filed by Valley Contax, Inc. with the FDA for Custom Stable Rigid Gas Permeable Scleral Contact Lens.

Pre-market Notification Details

Device IDK213880
510k NumberK213880
Device Name:Custom Stable Rigid Gas Permeable Scleral Contact Lens
ClassificationLens, Contact (other Material) - Daily
Applicant Valley Contax, Inc. 200 South Mill St. Springfield,  OR  97477
ContactJosh Adams
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 Received2021-12-13
Decision Date2022-01-07

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