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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 / September 2025 / K251843

510(k) cleared

Erchonia EVRL

Erchonia Corporation · Sep 12, 2025 · K251843

FDA cleared the Erchonia EVRL from Erchonia Corporation on Sep 12, 2025 under K251843, a traditional 510(k). The device falls under product code OLP, Over-The-Counter Powered Light Based Laser For Acne, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 16, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Erchonia Corporation has 2 other decisions in the tracker over the last 12 months: K251903 (Erchonia DPN Laser (Model# EVRL)), K252574 (Erchonia CLX (Model # CFL)).

Questions & Answers

What did FDA clear under K251843?

K251843 is the FDA 510(k) for Erchonia EVRL, submitted by Erchonia Corporation. FDA's decision date was Sep 12, 2025, under product code OLP (Over-The-Counter Powered Light Based Laser For Acne).

Who makes the Erchonia EVRL?

Erchonia Corporation, based in Fountain Inn, SC, is the applicant of record for K251843.

How long did the K251843 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on Sep 12, 2025, 88 days later.

← All decisions in September 2025

Sources