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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 / December 2025 / K251077

510(k) cleared

JOULE 1064nm System and Accessories

Sciton, Inc · Dec 19, 2025 · K251077

FDA cleared the JOULE 1064nm System and Accessories from Sciton, Inc on Dec 19, 2025 under K251077, 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 Apr 8, 2025. The decision came 255 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 Sciton, Inc in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251077?

K251077 is the FDA 510(k) for JOULE 1064nm System and Accessories, submitted by Sciton, Inc. FDA's decision date was Dec 19, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the JOULE 1064nm System and Accessories?

Sciton, Inc, based in Palo Alto, CA, is the applicant of record for K251077.

How long did the K251077 review take?

FDA received the submission on Apr 8, 2025 and issued its decision on Dec 19, 2025, 255 days later.

← All decisions in December 2025