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FDA 510(k)

Custom Stable Rigid Gas Permeable Scleral Contact Lens

K-Number: K213880 · 2022-01-07

ApplicantValley Contax, Inc.
Decision Date2022-01-07
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Custom Stable Rigid Gas Permeable Scleral Contact Lens is a medical device manufactured by Valley Contax, Inc.. It received FDA 510(k) clearance on 2022-01-07 under approval number K213880. 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 Rigid Gas Permeable Scleral Contact Lens?

Custom Stable Rigid Gas Permeable Scleral Contact Lens is a medical device that received FDA 510(k) clearance on 2022-01-07. It is manufactured by Valley Contax, Inc.. The 510(k) number is K213880.

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

Custom Stable Rigid Gas Permeable Scleral Contact Lens received FDA 510(k) clearance on 2022-01-07, under approval number K213880.

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

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

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

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

Related Clinical Trials

NCT07588659 Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD) NOT_YET_RECRUITING NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING NCT07288658 Comparing the Fit and Performance of Scleral Lenses With Oval and Circular Limbal Zones COMPLETED NCT07359638 Impact of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2 RECRUITING NCT07559188 Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus NOT_YET_RECRUITING NCT06848660 Study on Orthosis in Cervical Spine Fracture Treatment RECRUITING

Other Devices by Valley Contax, Inc.

K170335Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens 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)

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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