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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 / February 2026 / K251903

510(k) cleared

Erchonia DPN Laser (Model# EVRL)

Erchonia Corporation · Feb 19, 2026 · K251903

FDA cleared the Erchonia DPN Laser (Model# EVRL) from Erchonia Corporation on Feb 19, 2026 under K251903, a traditional 510(k). The device falls under product code NHN, Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, regulated at 21 CFR 890.5500 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jun 20, 2025. The decision came 244 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Erchonia Corporation has 2 other decisions in the tracker over the last 12 months: K252574 (Erchonia CLX (Model # CFL)), K251843 (Erchonia EVRL).

Questions & Answers

What did FDA clear under K251903?

K251903 is the FDA 510(k) for Erchonia DPN Laser (Model# EVRL), submitted by Erchonia Corporation. FDA's decision date was Feb 19, 2026, under product code NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy).

Who makes the Erchonia DPN Laser (Model# EVRL)?

Erchonia Corporation, based in Fountain Inn, SC, is the applicant of record for K251903.

How long did the K251903 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Feb 19, 2026, 244 days later.

← All decisions in February 2026

Sources