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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 / October 2025 / K251772

510(k) cleared

Navilas Laser System 577sl (156691)

Od-Os GmbH · Oct 29, 2025 · K251772

FDA cleared the Navilas Laser System 577sl (156691) from Od-Os GmbH on Oct 29, 2025 under K251772, 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 Jun 10, 2025. The decision came 141 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Od-Os GmbH has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K251772?

K251772 is the FDA 510(k) for Navilas Laser System 577sl (156691), submitted by Od-Os GmbH. FDA's decision date was Oct 29, 2025, under product code HQF (Laser, Ophthalmic).

Who makes the Navilas Laser System 577sl (156691)?

Od-Os GmbH, based in Teltow, is the applicant of record for K251772.

How long did the K251772 review take?

FDA received the submission on Jun 10, 2025 and issued its decision on Oct 29, 2025, 141 days later.

← All decisions in October 2025