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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 K073317
Device Name STARLIGHT, MODEL PD9012
Applicant
F.P. Rubinstein Y Cia S.R.L.
David Luque 519
Cordoba, Cba,  AR X5004AKM
Applicant Contact HAYDEE N DEMARCO
Correspondent
F.P. Rubinstein Y Cia S.R.L.
David Luque 519
Cordoba, Cba,  AR X5004AKM
Correspondent Contact HAYDEE N DEMARCO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/26/2007
Decision Date 09/03/2008
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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