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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 / November 2025 / K253123

510(k) cleared

CuRAS hybrid

Classys, Inc. · Nov 20, 2025 · K253123

FDA cleared the CuRAS hybrid from Classys, Inc. on Nov 20, 2025 under K253123, 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 Sep 25, 2025. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

Classys, Inc. has one other decision in the tracker over the last 12 months: K253504 (Volnewmer).

Questions & Answers

What did FDA clear under K253123?

K253123 is the FDA 510(k) for CuRAS hybrid, submitted by Classys, Inc.. FDA's decision date was Nov 20, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the CuRAS hybrid?

Classys, Inc., based in Seoul, is the applicant of record for K253123.

How long did the K253123 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Nov 20, 2025, 56 days later.

← All decisions in November 2025

Sources