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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K253760

510(k) cleared

OMNI Ultra Surgical System (1-110)

Sight Sciences, Inc. · Aug 4, 2026 · K253760

FDA cleared the OMNI Ultra Surgical System (1-110) from Sight Sciences, Inc. on Aug 4, 2026 under K253760, a traditional 510(k). The device falls under product code MRH, Pump, Infusion, Ophthalmic, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Nov 25, 2025. The decision came 252 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sight Sciences, Inc. has one other decision in the tracker over the last 12 months: K252409 (TearCare MGX System).

Questions & Answers

What did FDA clear under K253760?

K253760 is the FDA 510(k) for OMNI Ultra Surgical System (1-110), submitted by Sight Sciences, Inc.. FDA's decision date was Aug 4, 2026, under product code MRH (Pump, Infusion, Ophthalmic).

Who makes the OMNI Ultra Surgical System (1-110)?

Sight Sciences, Inc., based in Menlo Park, CA, is the applicant of record for K253760.

How long did the K253760 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Aug 4, 2026, 252 days later.

← All decisions in August 2026

Sources