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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 / May 2026 / K254234

510(k) cleared

Phototherapy System (DUV-COMBO)

Choyang Medics Co., Ltd. · May 1, 2026 · K254234

FDA cleared the Phototherapy System (DUV-COMBO) from Choyang Medics Co., Ltd. on May 1, 2026 under K254234, a traditional 510(k). The device falls under product code FTC, Light, Ultraviolet, Dermatological, regulated at 21 CFR 878.4630 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 29, 2025. The decision came 123 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 Choyang Medics Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254234?

K254234 is the FDA 510(k) for Phototherapy System (DUV-COMBO), submitted by Choyang Medics Co., Ltd.. FDA's decision date was May 1, 2026, under product code FTC (Light, Ultraviolet, Dermatological).

Who makes the Phototherapy System (DUV-COMBO)?

Choyang Medics Co., Ltd., based in Seongnam-Si, is the applicant of record for K254234.

How long did the K254234 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on May 1, 2026, 123 days later.

← All decisions in May 2026