510(k) K252673
K252673 is an FDA 510(k) premarket notification submitted by Lacerta Life Science for the device "LacertaMatrix". The FDA issued a decision of Substantially Equivalent on December 22, 2025. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2025
- Date Received
- August 25, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type