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510(k) Data Aggregation
K Number
K971875Device Name
OPTIM-EYES 450
Manufacturer
Date Cleared
1997-06-13
(24 days)
Product Code
Regulation Number
886.5850Why did this record match?
Applicant Name (Manufacturer) :
TAYLOR/FOX ENTERPRISES, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Optim-Eyes 450 sunglasses are worn by persons to protect the eyes from bright sunlight, including 100% and UVB, and blue light up to 450 nanometers.
Device Description
The Optim-Eyes 450 are non-prescription sunglasses constructed of commonly used materials for sunglass and spectacle frames and lenses.
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