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510(k) Data Aggregation
K Number
K081477Device Name
LUXTEC MLX LIGHT SOURCE
Manufacturer
INTEGRA LUXTEC, INC.
Date Cleared
2008-06-18
(22 days)
Product Code
FCW
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA LUXTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure.
The Integra Luxtec MLX Light Source should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye.
Device Description
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