AcuPulse W CO2 Laser Systems, Delivery Devices And Accessories

Powered Laser Surgical Instrument

Lumenis Ltd.

The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Acupulse W Co2 Laser Systems, Delivery Devices And Accessories.

Pre-market Notification Details

Device IDK202428
510k NumberK202428
Device Name:AcuPulse W CO2 Laser Systems, Delivery Devices And Accessories
ClassificationPowered Laser Surgical Instrument
Applicant Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam,  IL 2069204
ContactShlomit Segman
CorrespondentShlomit Segman
Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam,  IL 2069204
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-25
Decision Date2020-10-22

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