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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 / February 2026 / K252561

510(k) cleared

BTL-754FF

BTL Industries, Inc. · Feb 18, 2026 · K252561

FDA cleared the BTL-754FF from BTL Industries, Inc. on Feb 18, 2026 under K252561, 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 Aug 13, 2025. The decision came 189 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

BTL Industries, Inc. has 2 other decisions in the tracker over the last 12 months: K252963 (BTL-899TT), K253750 (BTL-785NEH).

Questions & Answers

What did FDA clear under K252561?

K252561 is the FDA 510(k) for BTL-754FF, submitted by BTL Industries, Inc.. FDA's decision date was Feb 18, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the BTL-754FF?

BTL Industries, Inc., based in Marlborough, MA, is the applicant of record for K252561.

How long did the K252561 review take?

FDA received the submission on Aug 13, 2025 and issued its decision on Feb 18, 2026, 189 days later.

← All decisions in February 2026

Sources