LacertaMatrix— 510(k) K260218
Substantially EquivalentLacerta Life Sciences
FDA 510(k) clearance K260218 for LacertaMatrix, Substantially Equivalent on 2026-02-19. Applicant: Lacerta Life Sciences. Device class: Unclassified.
Summary
Lacerta Life Sciences' LacertaMatrix is filed under product code KGN (Wound Dressing With Animal-Derived Material(S)). The record doesn't describe the product beyond its name and that code name.
Class U, with no regulation number. The classification panel is listed as Unknown, and the General, Plastic Surgery review panel handled it as a Special 510(k).
Lacerta Life Sciences filed from Woodstock, Georgia. Review took 27 calendar days (January 23 to February 19, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Lacerta Life Sciences
- Product code
- Product code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Woodstock, GA, US
Recent devices under product code KGN
view allAdverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.