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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 K934211
Device Name CYTOCARE DIODE LASER SYSTEM
Applicant
Cytocare, Inc.
9975 Toledo Way
Irvine,  CA  92718
Applicant Contact MARK CHERNEY
Correspondent
Cytocare, Inc.
9975 Toledo Way
Irvine,  CA  92718
Correspondent Contact MARK CHERNEY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/30/1993
Decision Date 05/17/1994
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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