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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 / October 2025 / K253355

510(k) cleared

Difiney Advanced Anti Snoring Device 4.0

Fissiontech, LLC · Oct 29, 2025 · K253355

FDA cleared the Difiney Advanced Anti Snoring Device 4.0 from Fissiontech, LLC on Oct 29, 2025 under K253355, a special 510(k). The device falls under product code LRK, Device, Anti-Snoring, regulated at 21 CFR 872.5570 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 30, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K253355?

K253355 is the FDA 510(k) for Difiney Advanced Anti Snoring Device 4.0, submitted by Fissiontech, LLC. FDA's decision date was Oct 29, 2025, under product code LRK (Device, Anti-Snoring).

Who makes the Difiney Advanced Anti Snoring Device 4.0?

Fissiontech, LLC, based in New York, NY, is the applicant of record for K253355.

How long did the K253355 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Oct 29, 2025, 29 days later.

← All decisions in October 2025