BondEase 2 Topical Skin Adhesive
K-Number: K243990 · 2025-09-19
ApplicantOptmed, Inc.
Decision Date2025-09-19
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
BondEase 2 Topical Skin Adhesive is a medical device manufactured by Optmed, Inc.. It received FDA 510(k) clearance on 2025-09-19 under approval number K243990. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BondEase 2 Topical Skin Adhesive?
BondEase 2 Topical Skin Adhesive is a medical device that received FDA 510(k) clearance on 2025-09-19. It is manufactured by Optmed, Inc.. The 510(k) number is K243990.
When was BondEase 2 Topical Skin Adhesive approved by the FDA?
BondEase 2 Topical Skin Adhesive received FDA 510(k) clearance on 2025-09-19, under approval number K243990.
What company makes BondEase 2 Topical Skin Adhesive?
BondEase 2 Topical Skin Adhesive is manufactured by Optmed, Inc..
What is the FDA product code for BondEase 2 Topical Skin Adhesive?
The FDA product code for BondEase 2 Topical Skin Adhesive is MPN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.