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FDA 510(k)

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

K-Number: K221768 · 2023-05-05

ApplicantParagon Vision Sciences, Inc.
Decision Date2023-05-05
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses is a medical device manufactured by Paragon Vision Sciences, Inc.. It received FDA 510(k) clearance on 2023-05-05 under approval number K221768. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses?

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses is a medical device that received FDA 510(k) clearance on 2023-05-05. It is manufactured by Paragon Vision Sciences, Inc.. The 510(k) number is K221768.

When was Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses approved by the FDA?

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses received FDA 510(k) clearance on 2023-05-05, under approval number K221768.

What company makes Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses?

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses is manufactured by Paragon Vision Sciences, Inc..

What is the FDA product code for Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses?

The FDA product code for Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses is HQD.

Related Clinical Trials

NCT06864858 Clinical Evaluation of Two Cosmetic Contact Lenses COMPLETED NCT07566234 Evaluation of Contact Lenses and Myopia. NOT_YET_RECRUITING NCT07600645 Contact Lens Trial Fitting Experience NOT_YET_RECRUITING NCT06749496 Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear COMPLETED NCT07586982 Clinical Performance of Verofilcon A Toric Contact Lenses RECRUITING NCT07076160 Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses COMPLETED

Related Devices (Code: HQD)

K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. K153714SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear CoSynergeyes, Inc. K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd. K160938SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc. K161461BostonSight PD Prosthetic DeviceBostonsight K152724EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSESAdvanced Vision Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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