Cleared Traditional

K252673 - LacertaMatrix (FDA 510(k) Clearance)

Dec 2025
Decision
119d
Days
-
Risk

K252673 is an FDA 510(k) clearance for the LacertaMatrix. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Lacerta Life Science (Broussard, US). The FDA issued a Cleared decision on December 22, 2025, 119 days after receiving the submission on August 25, 2025.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K252673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2025
Decision Date December 22, 2025
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KGN - Wound Dressing With Animal-derived Material(s)
Device Class -