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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 / K250776

510(k) cleared

Lithoblast Single Use Holmium Laser Fibers

Dawell Medical, LLC · Oct 14, 2025 · K250776

FDA cleared the Lithoblast Single Use Holmium Laser Fibers from Dawell Medical, LLC on Oct 14, 2025 under K250776, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 14, 2025. The decision came 214 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 Dawell Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250776?

K250776 is the FDA 510(k) for Lithoblast Single Use Holmium Laser Fibers, submitted by Dawell Medical, LLC. FDA's decision date was Oct 14, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Lithoblast Single Use Holmium Laser Fibers?

Dawell Medical, LLC, based in Miami, FL, is the applicant of record for K250776.

How long did the K250776 review take?

FDA received the submission on Mar 14, 2025 and issued its decision on Oct 14, 2025, 214 days later.

← All decisions in October 2025