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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 K952755
Device Name POWERSCULPTOR PROBES
Applicant
Cardiogenes
P.O. Box 50875
Palo Alto,  CA  94303
Applicant Contact ANNE-MARIE DE MERLIER
Correspondent
Cardiogenes
P.O. Box 50875
Palo Alto,  CA  94303
Correspondent Contact ANNE-MARIE DE MERLIER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/15/1995
Decision Date 09/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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