Alma Diode Tabletop Laser

Powered Laser Surgical Instrument

ALMA LTD

The following data is part of a premarket notification filed by Alma Ltd with the FDA for Alma Diode Tabletop Laser.

Pre-market Notification Details

Device IDK160952
510k NumberK160952
Device Name:Alma Diode Tabletop Laser
ClassificationPowered Laser Surgical Instrument
Applicant ALMA LTD 14 Halamish St Caesarea Industrial Park Caesarea,  IL 38900
ContactAriela Albalak
CorrespondentKathy Maynor
Kathy Maynor 26 Rebecca Ct Homosassa,  FL  34446
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-05
Decision Date2016-05-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290110120723 K160952 000

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