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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 / K251464

510(k) cleared

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)

Jeisys Medical Incorporated · Oct 3, 2025 · K251464

FDA cleared the TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) from Jeisys Medical Incorporated on Oct 3, 2025 under K251464, 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 May 13, 2025. The decision came 143 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 Jeisys Medical Incorporated in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251464?

K251464 is the FDA 510(k) for TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit), submitted by Jeisys Medical Incorporated. FDA's decision date was Oct 3, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)?

Jeisys Medical Incorporated, based in Seoul, is the applicant of record for K251464.

How long did the K251464 review take?

FDA received the submission on May 13, 2025 and issued its decision on Oct 3, 2025, 143 days later.

← All decisions in October 2025