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# Glaukos 510(k) Cleared for Intraocular Pressure
- URL: https://www.fdaweb.com/glaukos-510-k-cleared-for-intraocular-pressure/
- Published: 2022-08-03T12:00:00.000Z
- Updated: 2026-09-14T17:54:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152440

FDA has cleared a Glaukos 510(k) for its iStent Infinite Trabecular Micro-Bypass System and its use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma uncontrolled by prior medical and surgical therapy. The device comprises three heparin-coated titanium stents that are preloaded into an auto-injection system that allows a surgeon to inject them across a span of up to six hours around Schlemm’s canal, the eye’s primary drainage channel, according to the company. “Once in place, the stents are designed to lower IOP by restoring the natural, physiological outflow of aqueous humor,” it says.