WHERE ARE YOU?

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 / October 2025 / K252093

510(k) cleared

Light Therapy Mask (1019055)

Merchsource, LLC · Oct 16, 2025 · K252093

FDA cleared the Light Therapy Mask (1019055) from Merchsource, LLC on Oct 16, 2025 under K252093, 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 Jul 3, 2025. The decision came 105 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Merchsource, LLC has 2 other decisions in the tracker over the last 12 months: K251531 (AIR COMPRESSION BOOTS 1018195,1018196), K252096 (Light Therapy Decollete Mask (1019135)).

Questions & Answers

What did FDA clear under K252093?

K252093 is the FDA 510(k) for Light Therapy Mask (1019055), submitted by Merchsource, LLC. FDA's decision date was Oct 16, 2025, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the Light Therapy Mask (1019055)?

Merchsource, LLC, based in Irvine, CA, is the applicant of record for K252093.

How long did the K252093 review take?

FDA received the submission on Jul 3, 2025 and issued its decision on Oct 16, 2025, 105 days later.

← All decisions in October 2025

Sources