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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 / K251973

510(k) cleared

Luminance Red Cold Sore Device (TN1927G)

Luminance Medical Ventures, Inc. · Sep 23, 2025 · K251973

FDA cleared the Luminance Red Cold Sore Device (TN1927G) from Luminance Medical Ventures, Inc. on Sep 23, 2025 under K251973, a traditional 510(k). The device falls under product code OKJ, Light Based Treatment For Cold Sores Herpes Simplex Virus-1, regulated at 21 CFR 878.4860 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 26, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Luminance Medical Ventures, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251973?

K251973 is the FDA 510(k) for Luminance Red Cold Sore Device (TN1927G), submitted by Luminance Medical Ventures, Inc.. FDA's decision date was Sep 23, 2025, under product code OKJ (Light Based Treatment For Cold Sores Herpes Simplex Virus-1).

Who makes the Luminance Red Cold Sore Device (TN1927G)?

Luminance Medical Ventures, Inc., based in Dallas, TX, is the applicant of record for K251973.

How long did the K251973 review take?

FDA received the submission on Jun 26, 2025 and issued its decision on Sep 23, 2025, 89 days later.

← All decisions in September 2025