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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 / July 2026 / K260598

510(k) cleared

5 Wavelength LED Facemask (TN2508)

iSMART Developments, Ltd. · Jul 24, 2026 · K260598

FDA cleared the 5 Wavelength LED Facemask (TN2508) from iSMART Developments, Ltd. on Jul 24, 2026 under K260598, a traditional 510(k). The device falls under product code OHS, Light Based Over The Counter Wrinkle Reduction, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Feb 24, 2026. The decision came 150 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 iSMART Developments, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260598?

K260598 is the FDA 510(k) for 5 Wavelength LED Facemask (TN2508), submitted by iSMART Developments, Ltd.. FDA's decision date was Jul 24, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the 5 Wavelength LED Facemask (TN2508)?

iSMART Developments, Ltd., based in Birmingham, is the applicant of record for K260598.

How long did the K260598 review take?

FDA received the submission on Feb 24, 2026 and issued its decision on Jul 24, 2026, 150 days later.

← All decisions in July 2026