Balance Ophthalmics has received FDA 510(k) clearance for a wireless-enabled, next-generation version of its FSYX Ocular Pressure Adjusting Pump (OPAP), a prescription device designed to lower intraocular pressure (IOP) during sleep in adults with open-angle glaucoma.
The updated FSYX system builds on the company’s De Novo-classified platform, which Balance Ophthalmics describes as the first device developed specifically for nocturnal IOP reduction. The next-generation version adds wireless communication, enabling eye care practices to access real-world patient usage data from at-home therapy.
FSYX, pronounced “physics,” combines a compact pump with pressure-modulating goggles worn during sleep. The system applies gentle negative pressure to the eyes, targeting a period when IOP often rises and conventional therapies may be less effective. The device is designed to be used alongside existing glaucoma treatments, including prior surgical interventions.
According to the company, FSYX has been evaluated across 12 clinical studies involving more than 600 eyes, demonstrating a 39%mean reduction in nighttime eye pressure, with no device-related serious adverse events reported.
Thomas W. Samuelson, Founding Partner and Attending Surgeon at Minnesota Eye Consultants, said many glaucoma patients progress at night, when IOP is highest and current therapies may be least effective. “The OPAP is the first device designed to protect them during that window,” he said. “The new wireless capability helps us detect, patient by patient, whether they're actually receiving that protection while resting comfortably in their own home.”
Seph Jensen, Chief Executive Officer of Balance Ophthalmics, said the 510(k) clearance “builds directly on the foundation” of the company’s De Novo classification. He added that wireless communication turns FSYX into a connected clinical tool by giving practices insight into patient behavior outside the clinic.
Balance Ophthalmics expects the next-generation wireless FSYX OPAP to become available to eye care practices in Q4 2026. The prescription-only device will be delivered directly to patients for home use.
Source: Balance Ophthalmics.
