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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 / May 2026 / K260788

510(k) cleared

Smylio Aligners

Smylio, Inc. · May 8, 2026 · K260788

FDA cleared the Smylio Aligners from Smylio, Inc. on May 8, 2026 under K260788, a traditional 510(k). The device falls under product code NXC, Aligner, Sequential, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 10, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Smylio, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260788?

K260788 is the FDA 510(k) for Smylio Aligners, submitted by Smylio, Inc.. FDA's decision date was May 8, 2026, under product code NXC (Aligner, Sequential).

Who makes the Smylio Aligners?

Smylio, Inc., based in Fremont, CA, is the applicant of record for K260788.

How long did the K260788 review take?

FDA received the submission on Mar 10, 2026 and issued its decision on May 8, 2026, 59 days later.

← All decisions in May 2026