510(k) K243990
K243990 is an FDA 510(k) premarket notification submitted by Optmed, Inc. for the device "BondEase 2 Topical Skin Adhesive". The FDA issued a decision of Substantially Equivalent on September 19, 2025. The device falls under product code MPN (Tissue Adhesive For The Topical Approximation Of Skin), a Class II device regulated under 21 CFR 878.4010. Optmed, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2025
- Date Received
- December 26, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tissue Adhesive For The Topical Approximation Of Skin
- Device Class
- Class II
- Regulation Number
- 878.4010
- Review Panel
- SU
- Submission Type
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).