K-number	K221768
Device name	Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
Applicant	Paragon Vision Sciences, Inc.
Product code	HQD
Device class	Class II
Decision date	May 5, 2023
Decision	Substantially Equivalent
Regulation	886.5916

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View the full FDA submission: accessdata.fda.gov

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Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses

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