ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060

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 Family Of Thermo-xel Handpieces, Pixel Models: 2940, 1060.

Pre-market Notification Details

Device IDK072182
510k NumberK072182
Device Name:ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060
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 Received2007-08-06
Decision Date2008-06-27
Summary:summary

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