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510(k) K260218

LacertaMatrix by Lacerta Life Sciences — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2026
Date Received
January 23, 2026
Clearance Type
Special
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

Other clearances for product code KGN

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  • K253339 — Theracor (December 22, 2025)
  • K250864 — MatriDerm pluS+ Bi-Layer (December 19, 2025)
  • K242100 — SurgiAid Collagen Wound Dressing (HA) (October 16, 2025)
  • K252001 — Collagen Wound Dressing (October 10, 2025)
  • K250397 — Helios Dermal Scaffold (August 15, 2025)
  • K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (July 16, 2025)
  • K250329 — GeniPhys Collymer Self-Assembling Scaffold (June 25, 2025)