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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 K170738
Device Name InMode Diolaze XL
Applicant
Inmode MD , Ltd.
Tabor Bldg., Shaar Yokneam
Yokneam,  IL 2066509
Applicant Contact Amit Goren
Correspondent
A. Stein-Regulatory Affairs Consulting, Ltd.
20 Hata'As St., Suite 102
Kfar Saba,  IL 44425
Correspondent Contact Amit Goren
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/10/2017
Decision Date 08/07/2017
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
Predetermined Change
Control Plan Authorized		 No
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