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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K160195
Device Name Forma System, Forma Light System
Applicant
Formatk Systems , Ltd.
3 Hayozma St.
Tirat Carmel,  IL 3903203
Applicant Contact AMIT GOREN
Correspondent
A. Stein - Regulatory Affairs Consulting , Ltd.
20 Hata'As St. , Suite 102
K Far Saba,  IL 4442520
Correspondent Contact AMIT GOREN
Regulation Number878.4810
Classification Product Code
ONF  
Subsequent Product Codes
GFE   ILY   PBX  
Date Received01/27/2016
Decision Date 04/15/2016
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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