K Number
K250464Device Name
Enlight 2100 (TPL-E2103-0)Manufacturer
Date Cleared
2025-09-10
(204 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
ANReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A