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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 / March 2026 / K253965

510(k) cleared

CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)

Wuhan PHOMED Technology Company , Ltd. · Mar 19, 2026 · K253965

FDA cleared the CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) from Wuhan PHOMED Technology Company , Ltd. on Mar 19, 2026 under K253965, a traditional 510(k). The device falls under product code ILY, Lamp, Infrared, Therapeutic Heating, regulated at 21 CFR 890.5500 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Dec 11, 2025. The decision came 98 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 Wuhan PHOMED Technology Company , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253965?

K253965 is the FDA 510(k) for CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.), submitted by Wuhan PHOMED Technology Company , Ltd.. FDA's decision date was Mar 19, 2026, under product code ILY (Lamp, Infrared, Therapeutic Heating).

Who makes the CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)?

Wuhan PHOMED Technology Company , Ltd., based in Wuhan, is the applicant of record for K253965.

How long did the K253965 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on Mar 19, 2026, 98 days later.

← All decisions in March 2026