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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 K170060
Device Name M22 and ResurFx Systems
Applicant
Lumenis, Ltd.
6 Hakidma St. P.O. Box 240
Yokneam,  IL 2069204
Applicant Contact Naama Jacoby
Correspondent
Lumenis, Ltd.
6 Hakidma St. P.O. Box 240
Yokneam,  IL 2069204
Correspondent Contact Naama Jacoby
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ONF   ONG  
Date Received01/06/2017
Decision Date 08/09/2017
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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