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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 / K252273

510(k) cleared

Therapy US

Dmc Importação E Exportação DE Equipamentos Ltda · Dec 12, 2025 · K252273

FDA cleared the Therapy US from Dmc Importação E Exportação DE Equipamentos Ltda on Dec 12, 2025 under K252273, 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 Jul 22, 2025. The decision came 143 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 Dmc Importação E Exportação DE Equipamentos Ltda in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252273?

K252273 is the FDA 510(k) for Therapy US, submitted by Dmc Importação E Exportação DE Equipamentos Ltda. FDA's decision date was Dec 12, 2025, under product code NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy).

Who makes the Therapy US?

Dmc Importação E Exportação DE Equipamentos Ltda, based in São Carlos, is the applicant of record for K252273.

How long did the K252273 review take?

FDA received the submission on Jul 22, 2025 and issued its decision on Dec 12, 2025, 143 days later.

← All decisions in December 2025

Sources