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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 / July 2026 / K261847

510(k) cleared

iTero Lumina Pro

Align Technology , Ltd. · Jul 2, 2026 · K261847

FDA cleared the iTero Lumina Pro from Align Technology , Ltd. on Jul 2, 2026 under K261847, a special 510(k). The device falls under product code NTK, Light Transmission Caries Detector, regulated at 21 CFR 872.1745 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 3, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Align Technology , Ltd. has 2 other decisions in the tracker over the last 12 months: K252931 (Invisalign® Palatal Expander System), K252870 (Invisalign Specifix Attachment System).

Questions & Answers

What did FDA clear under K261847?

K261847 is the FDA 510(k) for iTero Lumina Pro, submitted by Align Technology , Ltd.. FDA's decision date was Jul 2, 2026, under product code NTK (Light Transmission Caries Detector).

Who makes the iTero Lumina Pro?

Align Technology , Ltd., based in Petach Tikva, is the applicant of record for K261847.

How long did the K261847 review take?

FDA received the submission on Jun 3, 2026 and issued its decision on Jul 2, 2026, 29 days later.

← All decisions in July 2026

Sources