# K243990: BondEase 2 Topical Skin Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Optmed, Inc.
- Decided: Sep 19, 2025 after 267 days
- Product code: MPN (Tissue Adhesive For The Topical Approximation Of Skin)
- Device class: 2
- Regulation: 21 CFR 878.4010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P960052 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152096: DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive, ETHICON, Inc. (2015) Summary page 5.
- K141157: Bondease Topical Skin Adhesive, Optmed, Inc. (2015) Summary page 5.

## Indications for use
BondEase® 2 Topical Skin Adhesive is intended for topical use only, to hold together the skin edges of incisions and lacerations that are under minimal tension and easily approximated. Where significant tension exists on incisions or lacerations, BondEase® 2 Topical Skin Adhesive should be used in conjunction with deep dermal stitches.

Source page: https://510kreport.com/device/K243990
Methodology: https://510kreport.com/methodology