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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 K203544
Device Name UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
Applicant
Lumenis, Ltd.
6 Hakidma St. P.O. Box 240
Yokneam,  IL 2069204
Applicant Contact Shlomit Segman
Correspondent
Lumenis, Ltd.
6 Hakidma St. P.O. Box 240
Yokneam,  IL 2069204
Correspondent Contact Shlomit Segman
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/04/2020
Decision Date 12/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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