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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 / K251699

510(k) cleared

The Botticelli (Model: Athena)

Bellamia Technologies, Inc. · Oct 8, 2025 · K251699

FDA cleared the The Botticelli (Model: Athena) from Bellamia Technologies, Inc. on Oct 8, 2025 under K251699, 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 Jun 2, 2025. The decision came 128 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 Bellamia Technologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251699?

K251699 is the FDA 510(k) for The Botticelli (Model: Athena), submitted by Bellamia Technologies, Inc.. FDA's decision date was Oct 8, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the The Botticelli (Model: Athena)?

Bellamia Technologies, Inc., based in Altamonte Springs, FL, is the applicant of record for K251699.

How long did the K251699 review take?

FDA received the submission on Jun 2, 2025 and issued its decision on Oct 8, 2025, 128 days later.

← All decisions in October 2025