WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / June 2026 / K253131

510(k) cleared

Curing Light (M-Cure 6)

Guangzhou Rebornendo Medical Instrument Co., Ltd. · Jun 18, 2026 · K253131

FDA cleared the Curing Light (M-Cure 6) from Guangzhou Rebornendo Medical Instrument Co., Ltd. on Jun 18, 2026 under K253131, a traditional 510(k). The device falls under product code EBZ, Activator, Ultraviolet, For Polymerization, regulated at 21 CFR 872.6070 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 25, 2025. The decision came 266 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 Guangzhou Rebornendo Medical Instrument Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253131?

K253131 is the FDA 510(k) for Curing Light (M-Cure 6), submitted by Guangzhou Rebornendo Medical Instrument Co., Ltd.. FDA's decision date was Jun 18, 2026, under product code EBZ (Activator, Ultraviolet, For Polymerization).

Who makes the Curing Light (M-Cure 6)?

Guangzhou Rebornendo Medical Instrument Co., Ltd., based in Guangzhou, is the applicant of record for K253131.

How long did the K253131 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Jun 18, 2026, 266 days later.

← All decisions in June 2026