FDA Clears Nocturnal IOP Device - Summary - MDSpire

FDA Clears Nocturnal IOP Device

Balance Ophthalmics gains FDA 510(k) clearance for wireless FSYX glaucoma device

  • May 26, 2026

  • 2 min

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Objective:

To announce the FDA 510(k) clearance of the FSYX Ocular Pressure Adjusting Pump (OPAP) for lowering intraocular pressure during sleep in adults with open-angle glaucoma.

Key Findings:
  • The FSYX OPAP is the first device specifically designed for nocturnal IOP reduction.
  • No serious device-related adverse events were reported in clinical studies.
  • The device is intended to be used alongside existing glaucoma treatments.
Interpretation:

The OPAP addresses the issue of elevated IOP during nighttime when conventional therapies may be less effective.

Limitations:
  • The device is prescription-only and will be available to eye care practices in Q4 2026.
Conclusion:

The FSYX OPAP represents a significant advancement in the management of glaucoma by targeting nighttime IOP.

Original Source(s)

FDA Clears Nocturnal IOP Device

  • May 26, 2026

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