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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 / April 2026 / K252409

510(k) cleared

TearCare MGX System

Sight Sciences, Inc. · Apr 27, 2026 · K252409

FDA cleared the TearCare MGX System from Sight Sciences, Inc. on Apr 27, 2026 under K252409, a traditional 510(k). The device falls under product code ORZ, Eyelid Thermal Pulsation System, regulated at 21 CFR 886.5200 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Aug 1, 2025. The decision came 269 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: K253760 (OMNI Ultra Surgical System (1-110)).

Questions & Answers

What did FDA clear under K252409?

K252409 is the FDA 510(k) for TearCare MGX System, submitted by Sight Sciences, Inc.. FDA's decision date was Apr 27, 2026, under product code ORZ (Eyelid Thermal Pulsation System).

Who makes the TearCare MGX System?

Sight Sciences, Inc., based in Menlo Park, CA, is the applicant of record for K252409.

How long did the K252409 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Apr 27, 2026, 269 days later.

← All decisions in April 2026

Sources