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FDA 510(k)

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

K-Number: K253822 · 2026-03-27

ApplicantZhuhai Fitlens Medical Technology Co., Ltd.
Decision Date2026-03-27
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses is a medical device manufactured by Zhuhai Fitlens Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-27 under approval number K253822. 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 GPA (hexafocon A) Rigid Gas Permeable Contact Lenses?

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by Zhuhai Fitlens Medical Technology Co., Ltd.. The 510(k) number is K253822.

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

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses received FDA 510(k) clearance on 2026-03-27, under approval number K253822.

What company makes GPA (hexafocon A) Rigid Gas Permeable Contact Lenses?

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses is manufactured by Zhuhai Fitlens Medical Technology Co., Ltd..

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

The FDA product code for GPA (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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