BostonSight® Specialty Lenses

BostonSight® Specialty Lenses is an FDA 510(k)-cleared medical device (K241571) manufactured by Boston Foundation For Sight, Inc. D/B/A Bostonsight. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 2024. Regulation: 8.