Cleared Special

LacertaMatrix

K260218 · Lacerta Life Sciences · General & Plastic Surgery
Feb 2026
Decision
27d
Days
Risk

About This 510(k) Submission

K260218 is an FDA 510(k) clearance for the LacertaMatrix, a Wound Dressing With Animal-derived Material(s), submitted by Lacerta Life Sciences (Woodstock, US). The FDA issued a Cleared decision on February 19, 2026, 27 days after receiving the submission on January 23, 2026. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K260218 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2026
Decision Date February 19, 2026
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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