Balance Ophthalmics, Inc. - FDA 510(k) Cleared Devices

Balance Ophthalmics, Inc. is dedicated to innovative ophthalmic solutions for glaucoma treatment. The company, based in Sioux Falls, South Dakota, focuses on non-pharmaceutical and non-surgical therapies to lower intraocular pressure. Their team brings over 100 years of specialized expertise in eye care research and development.

The company has received 1 FDA 510(k) clearance from 2 total submissions. Balance Ophthalmics specializes in ophthalmic devices, representing 100% of its regulatory submissions. The company achieved its first clearance in 2024 and remains active, with the latest clearance in 2026.

The FSYX Ocular Pressure Adjusting Pump represents the company's innovation in glaucoma management. This device offers patients a non-invasive option to manage intraocular pressure during sleep. Explore the company's cleared device names, product codes, and clearance dates in the regulatory database.