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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K220467
Device Name The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
Applicant
Lumenis Be, Ltd.
6 Hakidma Street PO BOX 240
Yokneam,  IL 2069204
Applicant Contact Shlomit Segman
Correspondent
Lumenis Be, Ltd.
6 Hakidma Street PO BOX 240
Yokneam,  IL 2069204
Correspondent Contact Shlomit Segman
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/17/2022
Decision Date 05/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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