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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 the device name listed in this FDA 510(k) record. The listed applicant is Valley Contax, Inc.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) 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. The listed applicant is Valley Contax, Inc.. The 510(k) number is K170335.

When did Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens receive FDA 510(k) clearance?

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

Who is the listed applicant for Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens?

The FDA 510(k) record lists Valley Contax, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07494799Efficacy of Different Interventions for Progressive Myopia After Orthokeratology Lens WearNOT_YET_RECRUITINGNCT07288658Comparing the Fit and Performance of Scleral Lenses With Oval and Circular Limbal ZonesCOMPLETEDNCT07559188Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and KeratoconusNOT_YET_RECRUITING

Other records listing Valley Contax, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213880Custom Stable Rigid Gas Permeable Scleral Contact LensK202860Valley 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)

Related Devices (Code: HQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A BostonsightK240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

Official Source

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

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