BondEase 2 Topical Skin Adhesive— 510(k) K243990
Substantially EquivalentOptmed, Inc.
FDA 510(k) clearance K243990 for BondEase 2 Topical Skin Adhesive, Substantially Equivalent on 2025-09-19. Applicant: Optmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Optmed, Inc.
- Product code
- Code MPN
- Device class
- Class 2
- Regulation
- 21 CFR 878.4010
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code MPN
view all- K250950 — CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739)
- K234114 — CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)
- K233458 — CM005 Standard (CM005); CM004 Mini (CM004)
- K230981 — Meriglu Topical Skin Adhesive
- K212246 — Exofin Precision Pen
More clearances from Optmed, Inc.
view allAdverse events under product code MPN
product code MPN- Injury
- 856
- Other
- 1
- Total
- 857
Source: openFDA MAUDE database, through . 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.