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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 / January 2026 / K252960

510(k) cleared

SOLIUS PRO UVB Light Panel

Solius Labs, Inc. · Jan 16, 2026 · K252960

FDA cleared the SOLIUS PRO UVB Light Panel from Solius Labs, Inc. on Jan 16, 2026 under K252960, a traditional 510(k). The device falls under product code SGZ, Ultraviolet Lamp Products, regulated at 21 CFR 878.4635 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 16, 2025. The decision came 122 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 Solius Labs, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252960?

K252960 is the FDA 510(k) for SOLIUS PRO UVB Light Panel, submitted by Solius Labs, Inc.. FDA's decision date was Jan 16, 2026, under product code SGZ (Ultraviolet Lamp Products).

Who makes the SOLIUS PRO UVB Light Panel?

Solius Labs, Inc., based in Bainbridge Island, WA, is the applicant of record for K252960.

How long did the K252960 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Jan 16, 2026, 122 days later.

← All decisions in January 2026