FUTURELASE 3000/3002 ERBIUM LASER SYSTEM

Powered Laser Surgical Instrument

BUCKMAN CO., INC.

The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Futurelase 3000/3002 Erbium Laser System.

Pre-market Notification Details

Device IDK974641
510k NumberK974641
Device Name:FUTURELASE 3000/3002 ERBIUM LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord,  CA  94520
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord,  CA  94520
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-15
Decision Date1998-06-08
Summary:summary

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