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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 / K252979

510(k) cleared

Voyager DSLT (430840610)

Belkin Vision, Ltd. · Apr 7, 2026 · K252979

FDA cleared the Voyager DSLT (430840610) from Belkin Vision, Ltd. on Apr 7, 2026 under K252979, a traditional 510(k). The device falls under product code HQF, Laser, Ophthalmic, regulated at 21 CFR 886.4390 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Sep 17, 2025. The decision came 202 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 Belkin Vision, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252979?

K252979 is the FDA 510(k) for Voyager DSLT (430840610), submitted by Belkin Vision, Ltd.. FDA's decision date was Apr 7, 2026, under product code HQF (Laser, Ophthalmic).

Who makes the Voyager DSLT (430840610)?

Belkin Vision, Ltd., based in Yavne, is the applicant of record for K252979.

How long did the K252979 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on Apr 7, 2026, 202 days later.

← All decisions in April 2026