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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 K073048
Device Name PETERIO UNIVERSAL LASER SCANNING HANDPIECE
Applicant
Scilex, Ltd.
Arlozorov 41a
Rishon Le Zion,  IL 75214
Applicant Contact ALEX RAPOPORT
Correspondent
Scilex, Ltd.
Arlozorov 41a
Rishon Le Zion,  IL 75214
Correspondent Contact ALEX RAPOPORT
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/29/2007
Decision Date 02/28/2008
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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