SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, And Accessories)

Powered Laser Surgical Instrument

Gyrus ACMI, Inc.

The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Soltive Laser System (soltive Pro Superpulsed Laser, Soltive Premium Superpulsed Laser, Soltive Laser Fibers, And Accessories).

Pre-market Notification Details

Device IDK211401
510k NumberK211401
Device Name:SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, And Accessories)
ClassificationPowered Laser Surgical Instrument
Applicant Gyrus ACMI, Inc. 800 West Park Drive Westborough,  MA  01581
ContactJulie Acker
CorrespondentJulie Acker
Gyrus ACMI, Inc. 800 West Park Drive Westborough,  MA  01581
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-06
Decision Date2021-06-03

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