FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Bausch + Lomb Receive 510(k) Clearance for Contact Lens Coating

Feb. 14, 2019
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Bausch + Lomb received 510(k) clearance for use of its Tangible Hydra-PEG custom contact lens coating technology with some of its Boston gas permeable lens materials.

The clearance allows the coating technology to be used with the company’s Boston XO, Boston XO2, Boston EO and Boston ES lenses, including products used in the Zenlens scleral lens range.

The high-water polymer coating bonds to the contact lens’ surface, helping to ease contact lens dryness and discomfort.

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