Balance Ophthalmics receives FDA 510(k) clearance for wireless-enabled nocturnal IOP device

Balance Ophthalmics has announced that the FDA has granted 510(k) clearance for a wireless-enabled, next-generation version of the FSYX ocular pressure adjusting pump (OPAP), a non-pharmacological, non-surgical device designed to reduce IOP during sleep in patients with glaucoma.¹ The clearance builds on the company’s previously granted De Novo classification for the FSYX platform.²

Device design and mechanism

The prescription-only FSYX system includes a compact pump and pressure-modulating goggles worn during sleep. According to the company, the device targets a period when IOP typically rises and conventional therapies may be less effective. The system is designed to be used alongside existing glaucoma therapies, including prior surgical interventions.¹

FSYX (pronounced “physics”) is described by the company as the first and only non-pharmacological, non-surgical treatment designed to lower IOP during sleep in patients with glaucoma. Across 12 clinical studies involving more than 600 eyes, the company reports that FSYX demonstrated a 39% mean reduction in nighttime IOP, with no device-related serious adverse events reported.^1,3

Wireless connectivity and clinical utility

The next-generation device adds wireless communication, enabling eye care practices to receive objective patient usage data from at-home therapy. According to the company, this functionality is intended to provide prescribing clinicians with visibility into therapy adherence.¹

Thomas W. Samuelson, MD, founding partner and attending surgeon at Minnesota Eye Consultants, commented on the clinical significance of the wireless feature: “Many [patients with] glaucoma progress at night when IOP runs highest and current therapies are least effective. The OPAP is the first device designed to protect them during that window. The new wireless capability helps us detect, patient by patient, whether they’re actually receiving that protection while resting comfortably in their own home.”¹

Seph Jensen, chief executive officer of Balance Ophthalmics, described the 510(k) clearance as building on the De Novo foundation: “Wireless communication transforms the device into a connected clinical tool, giving practices insight into patient behavior at home. We are proud to bring this capability to glaucoma patients and the practices that care for them.”¹

Availability and access

Balance Ophthalmics noted it anticipates availability of the next-generation wireless FSYX OPAP to eye care practices beginning in Q4 2026. The prescription-only device is delivered directly to patients for home use. Practices interested in learning more may contact Balance Ophthalmics at [email protected].¹

References

1. Balance Ophthalmics receives FDA 510(k) clearance for wireless-enabled next-generation FSYX ocular pressure adjusting pump. News release. Balance Ophthalmics. May 12, 2026. Accessed May 27, 2026. https://www.balanceophthalmics.com/fda-clearance-for-fsyx

2. Hutton D. FDA grants De Novo classification to Balance Ophthalmics’ FSYX ocular pressure adjusting pump. Ophthalmology Times. July 9, 2024. Accessed May 27, 2026. https://www.ophthalmologytimes.com/view/fda-grants-denovo-classification-to-balance-ophthalmics-fysx-ocular-pressure-adjusting-pump

3. Ferguson TJ, Samuelson TW, Herndon L, et al. Negative pressure application by the ocular pressure adjusting pump to lower intraocular pressure in normal-tension glaucoma: HERCULES Study. Am J Ophthalmol. 2025;275:121-134. doi:10.1016/j.ajo.2025.03.030