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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 / DEN240077

510(k) cleared

MuReva OM

Mureva Phototherapy, Inc. · Nov 26, 2025 · DEN240077

FDA cleared the MuReva OM from Mureva Phototherapy, Inc. on Nov 26, 2025 under DEN240077, a direct 510(k). The device falls under product code SGQ, Intraoral Phototherapy Device, regulated at 21 CFR 872.5595 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 23, 2024. The decision came 338 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 Mureva Phototherapy, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN240077?

DEN240077 is the FDA 510(k) for MuReva OM, submitted by Mureva Phototherapy, Inc.. FDA's decision date was Nov 26, 2025, under product code SGQ (Intraoral Phototherapy Device).

Who makes the MuReva OM?

Mureva Phototherapy, Inc., based in Strongsville, OH, is the applicant of record for DEN240077.

How long did the DEN240077 review take?

FDA received the submission on Dec 23, 2024 and issued its decision on Nov 26, 2025, 338 days later.

← All decisions in November 2025