WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / November 2025 / K250501

510(k) cleared

System Sophi

This AG · Nov 14, 2025 · K250501

FDA cleared the System Sophi from This AG on Nov 14, 2025 under K250501, a traditional 510(k). The device falls under product code HQC, Unit, Phacofragmentation, regulated at 21 CFR 886.4670 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Feb 20, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for This AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250501?

K250501 is the FDA 510(k) for System Sophi, submitted by This AG. FDA's decision date was Nov 14, 2025, under product code HQC (Unit, Phacofragmentation).

Who makes the System Sophi?

This AG, based in Heerbrugg, is the applicant of record for K250501.

How long did the K250501 review take?

FDA received the submission on Feb 20, 2025 and issued its decision on Nov 14, 2025, 267 days later.

← All decisions in November 2025