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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 / K253100

510(k) cleared

MultiPulse TFL

Asclepion Laser Technologies GmbH · Oct 23, 2025 · K253100

FDA cleared the MultiPulse TFL from Asclepion Laser Technologies GmbH on Oct 23, 2025 under K253100, a special 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 Sep 24, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Asclepion Laser Technologies GmbH has one other decision in the tracker over the last 12 months: K261094 (YellowStar).

Questions & Answers

What did FDA clear under K253100?

K253100 is the FDA 510(k) for MultiPulse TFL, submitted by Asclepion Laser Technologies GmbH. FDA's decision date was Oct 23, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the MultiPulse TFL?

Asclepion Laser Technologies GmbH, based in Jena, is the applicant of record for K253100.

How long did the K253100 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Oct 23, 2025, 29 days later.

← All decisions in October 2025

Sources