MANTA Laser

Powered Laser Surgical Instrument

SQUALUS MED Ltd.

The following data is part of a premarket notification filed by Squalus Med Ltd. with the FDA for Manta Laser.

Pre-market Notification Details

Device IDK222701
510k NumberK222701
Device Name:MANTA Laser
ClassificationPowered Laser Surgical Instrument
Applicant SQUALUS MED Ltd. 7 HaEshel Street Caesarea,  IL 3088900
ContactGil Shapira
CorrespondentGil Shapira
SQUALUS MED Ltd. 7 HaEshel Street Caesarea,  IL 3088900
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-07
Decision Date2022-11-18

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