ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES

Powered Laser Surgical Instrument

ALMA LASERS LTD.

The following data is part of a premarket notification filed by Alma Lasers Ltd. with the FDA for Alma Lasers Thermoxel Co2 Laser System And Delivery Device Accessories.

Pre-market Notification Details

Device IDK080463
510k NumberK080463
Device Name:ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES
ClassificationPowered Laser Surgical Instrument
Applicant ALMA LASERS LTD. 3637 BERNAL AVE. Pleasanton,  CA  94566
ContactAnne Worden
CorrespondentAnne Worden
ALMA LASERS LTD. 3637 BERNAL AVE. Pleasanton,  CA  94566
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-20
Decision Date2008-07-23
Summary:summary

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