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FDA 510(k)

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens

K-Number: K170335 · 2017-03-24

ApplicantValley Contax, Inc.
Decision Date2017-03-24
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens is a medical device manufactured by Valley Contax, Inc.. It received FDA 510(k) clearance on 2017-03-24 under approval number K170335. 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 Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens?

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Valley Contax, Inc.. The 510(k) number is K170335.

When was Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens approved by the FDA?

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens received FDA 510(k) clearance on 2017-03-24, under approval number K170335.

What company makes Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens?

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens is manufactured by Valley Contax, Inc..

What is the FDA product code for Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens?

The FDA product code for Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens is HQD.

Related Clinical Trials

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Other Devices by Valley Contax, Inc.

K202860Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) K213880Custom Stable Rigid Gas Permeable Scleral Contact Lens

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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