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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Sight Sciences' OMNI Ultra Glaucoma Surgery System

The single-use device combines canaloplasty and trabeculotomy through one small corneal incision; a US launch is planned for the fourth quarter.

By News DeskAugust 5, 20262 min read
Cross-section illustration of the front of the eye labelling the cornea, lens, meshwork and sclera, with an arrow showing fluid draining
A National Eye Institute diagram of conventional glaucoma surgery, showing fluid leaving the eye through a new opening. Not the OMNI Ultra procedure. National Eye Institute, NIH, Public domain, via Wikimedia Commons · Public domain (work of the National Eye Institute, NIH)
FDA cleared510(k) · K253760FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA found Sight Sciences' submission K253760 for the OMNI Ultra Surgical System substantially equivalent on August 4, 2026.
  • The device is indicated for canaloplasty followed by trabeculotomy to reduce eye pressure in adults with primary open-angle glaucoma.
  • Sight Sciences says the system performs canaloplasty in a single pass; it has not cited clinical outcome data specific to OMNI Ultra.

Sight Sciences said on August 4 that the US Food and Drug Administration has cleared its OMNI Ultra Surgical System, a handheld, single-use device for minimally invasive glaucoma surgery, for canaloplasty followed by trabeculotomy to lower eye pressure in adults with primary open-angle glaucoma, according to the Menlo Park, California, company's announcement.

The company said OMNI Ultra is the newest version of its OMNI platform and that a US commercial launch remains on track for the fourth quarter of 2026.

What the FDA record shows

The FDA's 510(k) database lists submission K253760 for the OMNI Ultra Surgical System (1-110) from Sight Sciences, Inc. The agency received the traditional 510(k) on November 25, 2025, and found the device substantially equivalent on August 4, 2026. The record classifies it under regulation 880.5725 as an ophthalmic infusion pump, product code MRH, with subsequent product code HMZ, reviewed by the ophthalmic panel. It shows no third-party review.

According to the company, the device is indicated for canaloplasty, described in the release as microcatheterization and viscodilation of Schlemm's canal, followed by trabeculotomy, the cutting of the trabecular meshwork. Like earlier OMNI versions, it is designed to address three areas of resistance in the eye's conventional fluid outflow pathway, the trabecular meshwork, Schlemm's canal and the collector channels, through a single clear corneal microincision without leaving an implant behind. It can be used on its own or together with cataract surgery, the company said.

What is new, according to the company

Sight Sciences said OMNI Ultra performs circumferential canaloplasty in a single pass and described it as the first FDA-cleared minimally invasive glaucoma surgery device to do so. A feature the company calls TruSync Plus is designed to control viscodilation as the microcatheter is advanced and withdrawn, and the company said the design also improves visualization of the catheter. The release does not cite clinical outcome data specific to OMNI Ultra; it says the OMNI platform is supported by prospective, real-world and long-term studies.

"With OMNI Ultra, we're building on the proven OMNI platform with enhanced control, procedural efficiency, and treatment precision, while maintaining the simplicity, reliability and efficacy surgeons trust," said Paul Badawi, Sight Sciences' co-founder and chief executive.

The company estimates that more than 350,000 procedures have been performed worldwide with OMNI-platform devices, based on units shipped as of June 30, 2026. Arkadiy Yadgarov, a surgeon who the company said took part in both the design and clinical evaluation of OMNI Ultra, was quoted in the release. Sight Sciences did not disclose pricing.

Sources

  1. Sight Sciences Receives FDA 510(k) Clearance of the OMNI Ultra Surgical System, Sight Sciences, August 4, 2026
  2. 510(k) Premarket Notification K253760: OMNI Ultra Surgical System (1-110), US Food and Drug Administration, August 4, 2026