BondEase 2 Topical Skin Adhesive— 510(k) K243990

Substantially Equivalent

Optmed, Inc.

FDA 510(k) clearance K243990 for BondEase 2 Topical Skin Adhesive, Substantially Equivalent on 2025-09-19. Applicant: Optmed, Inc..

Clearance details

Applicant: Optmed, Inc.
Product code: Code MPN
Advisory panel: General, Plastic Surgery
Date received: 2024-12-26
Decision date: 2025-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MPN

product code MPN

Injury: 856
Other: 1
Total: 857

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.