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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 K080731
Device Name PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
Applicant
Osyris
121 Rue Chanzy
Bp 90140
Hellemmes,  FR F59260
Applicant Contact JAOUAD ZEMMOURI
Correspondent
Osyris
121 Rue Chanzy
Bp 90140
Hellemmes,  FR F59260
Correspondent Contact JAOUAD ZEMMOURI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/14/2008
Decision Date 07/17/2008
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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