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 / June 2026 / K261174

510(k) cleared

RxSight® Insertion Device

Rxsight, Inc. · Jun 10, 2026 · K261174

FDA cleared the RxSight® Insertion Device from Rxsight, Inc. on Jun 10, 2026 under K261174, a special 510(k). The device falls under product code MSS, Folders And Injectors, Intraocular Lens (Iol), regulated at 21 CFR 886.4300 as a Class 1 device. The review panel was Ophthalmic.

FDA logged the submission as received on Apr 9, 2026. The decision came 62 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Rxsight, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261174?

K261174 is the FDA 510(k) for RxSight® Insertion Device, submitted by Rxsight, Inc.. FDA's decision date was Jun 10, 2026, under product code MSS (Folders And Injectors, Intraocular Lens (Iol)).

Who makes the RxSight® Insertion Device?

Rxsight, Inc., based in Aliso Viejo, CA, is the applicant of record for K261174.

How long did the K261174 review take?

FDA received the submission on Apr 9, 2026 and issued its decision on Jun 10, 2026, 62 days later.

← All decisions in June 2026