The Alma Hybrid Laser System

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 The Alma Hybrid Laser System.

Pre-market Notification Details

Device IDK203441
510k NumberK203441
Device Name:The Alma Hybrid Laser System
ClassificationPowered Laser Surgical Instrument
Applicant Alma Lasers, Ltd. 18 Haharash Street, North Industrial Park Caesarea Ha Zafon,  IL 3079895
ContactAvi Hirshnzon
CorrespondentAvi Hirshnzon
Alma Lasers, Ltd. 18 Haharash Street, North Industrial Park Caesarea Ha Zafon,  IL 3079895
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-07-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290110122147 K203441 000
17290110122130 K203441 000
17290110122123 K203441 000
17290110122116 K203441 000
17290110122109 K203441 000
17290110122093 K203441 000

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