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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 K173169
Device Name Rapid Family
Applicant
Sharplight Technologies, Ltd.
33 Lazarov St.
Rishon Le Zion,  IL 7565435
Applicant Contact Ilan Sharon
Correspondent
Ilan Sharon
A 109 Neot Golf
Caesarea,  IL
Correspondent Contact Ilan Sharon
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
GEI  
Date Received09/29/2017
Decision Date 11/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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