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Valley Contax gains 510(k) for Custom Stable GP scleral lens
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The FDA granted 510(k) premarket notification to Custom Stable Rigid Gas Permeable Contact Lens from Valley Contax.
Custom Stable lenses are manufactured in a way that consistently vaults the cornea with precision clearance and lands with smooth edges, according to the company website. The result is an optimal tear lens that floats the Custom Stable over the cornea for all-day comfort and good vision.
Four lens sizes are available: 14.8 mm for pediatrics, small apertures/corneas or when corneal clearance requirements are minimal; 15.8 mm, which company refers to as the “go-to lens,” combining a great amount of clearance options with a wider, softer landing zone; 16.8 mm, which allows a wider, softer landing zone, and 17.8 mm, with the highest sagittal option in the series for patients with large aperture, extreme clearance needs or previous scleral wear experience.
Patients and practitioners can also choose laser monogramming for additional customization.
Lenses are finished with a Digital Edge Radiusing and Plasma treatment system for a clean, wettable finish and good fit, according to the company.