WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K252574

510(k) cleared

Erchonia CLX (Model # CFL)

Erchonia Corporation · Dec 15, 2025 · K252574

FDA cleared the Erchonia CLX (Model # CFL) from Erchonia Corporation on Dec 15, 2025 under K252574, a traditional 510(k). The device falls under product code OLI, Fat Reducing Low Level Laser, regulated at 21 CFR 878.5400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 14, 2025. The decision came 123 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: K251903 (Erchonia DPN Laser (Model# EVRL)), K251843 (Erchonia EVRL).

Questions & Answers

What did FDA clear under K252574?

K252574 is the FDA 510(k) for Erchonia CLX (Model # CFL), submitted by Erchonia Corporation. FDA's decision date was Dec 15, 2025, under product code OLI (Fat Reducing Low Level Laser).

Who makes the Erchonia CLX (Model # CFL)?

Erchonia Corporation, based in Fountain Inn, SC, is the applicant of record for K252574.

How long did the K252574 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on Dec 15, 2025, 123 days later.

← All decisions in December 2025

Sources