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Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia

FDA classified the digital therapy device for amblyopia as Class II with special controls. The device uses dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or improve visual acuity. This action codifies a prior De Novo classification from October 20, 2021, allowing other manufacturers to use this device as a predicate for 510(k) clearance.