05.12.2026
Balance Ophthalmics Receives FDA 510(k) Clearance for Wireless-Enabled Ocular Pressure Adjusting Pump for Glaucoma
Balance Ophthalmics announced that the FDA has granted 510(k) clearance for a wireless-enabled, next-generation version of the FSYX Ocular Pressure Adjusting Pump (OPAP). The clearance builds on the company’s previously granted De Novo classification for the FSYX platform, which was the first device specifically designed to reduce nocturnal IOP in glaucoma patients.