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# Panel to Discuss Non-invasive Ocular Pump
- URL: https://www.fdaweb.com/panel-to-discuss-non-invasive-ocular-pump/
- Published: 2024-03-20T12:00:00.000Z
- Updated: 2026-09-14T14:25:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156593

The FDA Ophthalmic Devices Panel will discuss on 3/21 the *de novo* request from Balance Ophthalmics, Inc., for its FSYX Ocular Pressure Adjusting Pump. An agency [briefing document](https://www.fda.gov/media/177121/download?ref=fdaweb.com) released before the meeting says the device has a set of goggles connected to a pump. When the goggles are worn, it says, the pump creates negative pressure inside the space created by the goggles. The device is intended to be an adjunctive therapy to reduce intraocular pressure during nightly use in adults with open-angle glaucoma and a specified intraocular pressure.

The medical device reviewers note that currently marketed devices intended to reduce intraocular pressure are either implants or surgical devices and the proposed mechanism of action for the Balance Ophthalmics device is different than that of any of the currently cleared/approved devices for patients with glaucoma.

FDA traces its history with the device from the company’s initial submission in 2017\. Among the questions raised for the panel to discuss are:

- cybersecurity concerns;
- software;
- whether the available data support the proposed negative pressure programmable range and the proposed wear time;
- whether the device’s long-term safety has been demonstrated based on the availability of one-year safety data; and
- whether there is a reasonable assurance of overall safety.