K Number
K130168Device Name
CL10009 IR LASERManufacturer
Date Cleared
2014-01-10
(351 days)
Product Code
Regulation Number
890.5500Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A