Alma Diode Tabletop Laser

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 Diode Tabletop Laser.

Pre-market Notification Details

Device IDK212073
510k NumberK212073
Device Name:Alma Diode Tabletop Laser
ClassificationPowered Laser Surgical Instrument
Applicant Alma Lasers, Ltd. 18 Haharash Street, North Industrial Park Caesarea,  IL 3079895
ContactAvi Hirshnzon
CorrespondentConnie Hoy
Hoy & Associates Regulatory Consulting 1830 Bonnie Way Sacramento,  CA  95825
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-02
Decision Date2022-07-14

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.