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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 / December 2025 / K252633

510(k) cleared

UNITY DX (UDX)

Cylite Pty. , Ltd. · Dec 23, 2025 · K252633

FDA cleared the UNITY DX (UDX) from Cylite Pty. , Ltd. on Dec 23, 2025 under K252633, a traditional 510(k). The device falls under product code OBO, Tomography, Optical Coherence, regulated at 21 CFR 886.1570 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Aug 20, 2025. The decision came 125 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 Cylite Pty. , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252633?

K252633 is the FDA 510(k) for UNITY DX (UDX), submitted by Cylite Pty. , Ltd.. FDA's decision date was Dec 23, 2025, under product code OBO (Tomography, Optical Coherence).

Who makes the UNITY DX (UDX)?

Cylite Pty. , Ltd., based in Mulgrave, is the applicant of record for K252633.

How long did the K252633 review take?

FDA received the submission on Aug 20, 2025 and issued its decision on Dec 23, 2025, 125 days later.

← All decisions in December 2025