NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES

Powered Laser Surgical Instrument

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Novus 3000 Laser System And Delivery Devices.

Pre-market Notification Details

Device IDK052526
510k NumberK052526
Device Name:NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS, INC. 2400 CONDENSA ST. Santa Clara,  CA  95051 -0901
ContactKaren L Baker
CorrespondentKaren L Baker
LUMENIS, INC. 2400 CONDENSA ST. Santa Clara,  CA  95051 -0901
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-14
Decision Date2005-11-15
Summary:summary

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