VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500

Powered Laser Surgical Instrument

VASCULAR SOLUTIONS, INC.

The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vari-lase Endovenous Laser Console, Model 7500.

Pre-market Notification Details

Device IDK062822
510k NumberK062822
Device Name:VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500
ClassificationPowered Laser Surgical Instrument
Applicant VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
ContactPatrice Stromberg
CorrespondentPatrice Stromberg
VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis,  MN  55369
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-20
Decision Date2006-11-21
Summary:summary

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