| K-number | K243990 |
| Device name | BondEase 2 Topical Skin Adhesive |
| Applicant | Optmed, Inc. |
| Product code | MPN |
| Device class | Class II |
| Decision date | Sep 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4010 |
BondEase 2 Topical Skin Adhesive is a sterile, liquid topical skin closure device composed of methylidene malonate monomer. It is provided as a single-use applicator that mixes two solutions (Part A monomer and Part B activator) to polymerize and hold together skin edges of incisions and lacerations under minimal tension. For high-tension wounds, it should be used with deep dermal stitches.
The subject device uses the same methylidene malonate monomer formulation and is identical in design and manufacturing to the reference device TearRepair (K241916), except for the plastic handle. Compared to the primary predicate Dermabond Advanced (K152096), it has a different formulation and dispenser design but identical principle of operation and mechanism of action. It shares the same monomer as the predicate BondEase (K141157).
ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation), ISO 10993-11 (acute systemic toxicity, pyrogenicity), ISO 10993-6 (implantation), ASTM F2458-05 (wound closure strength), ASTM F2258-05 (tensile strength), ASTM F2255-05 (lap-shear strength), USP <151> (pyrogen testing).
Although BondEase 2 differs from Dermabond Advanced in formulation and dispenser design, these differences do not impact indications for use, principle of operation, mechanism of action, or conditions of use—all of which remain identical to the primary predicate. BondEase 2 uses the same monomer as the earlier BondEase predicate for the same intended use. Performance testing (adhesive strength, hydrolytic degradation, heat of polymerization, microbial barrier, applicator functionality) and animal testing confirm the device does not raise different safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov