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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 / K243990

510(k) cleared

BondEase 2 Topical Skin Adhesive

Optmed, Inc. · Sep 19, 2025 · K243990

FDA cleared the BondEase 2 Topical Skin Adhesive from Optmed, Inc. on Sep 19, 2025 under K243990, a traditional 510(k). The device falls under product code MPN, Tissue Adhesive For The Topical Approximation Of Skin, regulated at 21 CFR 878.4010 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 26, 2024. The decision came 267 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 Optmed, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243990?

K243990 is the FDA 510(k) for BondEase 2 Topical Skin Adhesive, submitted by Optmed, Inc.. FDA's decision date was Sep 19, 2025, under product code MPN (Tissue Adhesive For The Topical Approximation Of Skin).

Who makes the BondEase 2 Topical Skin Adhesive?

Optmed, Inc., based in New York, NY, is the applicant of record for K243990.

How long did the K243990 review take?

FDA received the submission on Dec 26, 2024 and issued its decision on Sep 19, 2025, 267 days later.

← All decisions in September 2025