IMAGE VASCULAR LASER

Powered Laser Surgical Instrument

SCITON, INC.

The following data is part of a premarket notification filed by Sciton, Inc. with the FDA for Image Vascular Laser.

Pre-market Notification Details

Device IDK003046
510k NumberK003046
Device Name:IMAGE VASCULAR LASER
ClassificationPowered Laser Surgical Instrument
Applicant SCITON, INC. 845 COMMERCIAL AVE. Palo Alto,  CA  94303
ContactPeter Allen
CorrespondentPeter Allen
SCITON, INC. 845 COMMERCIAL AVE. Palo Alto,  CA  94303
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-29
Decision Date2000-11-24

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