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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 / August 2026 / K253795

510(k) cleared

MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

Menicon Co, Ltd. · Aug 13, 2026 · K253795

FDA cleared the MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution from Menicon Co, Ltd. on Aug 13, 2026 under K253795, a traditional 510(k). The device falls under product code LPN, Accessories, Soft Lens Products, regulated at 21 CFR 886.5928 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Nov 28, 2025. The decision came 258 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 Menicon Co, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253795?

K253795 is the FDA 510(k) for MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution, submitted by Menicon Co, Ltd.. FDA's decision date was Aug 13, 2026, under product code LPN (Accessories, Soft Lens Products).

Who makes the MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution?

Menicon Co, Ltd., based in Nagoya, is the applicant of record for K253795.

How long did the K253795 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Aug 13, 2026, 258 days later.

← All decisions in August 2026