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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 K013201
Device Name CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
Applicant
Cardiofocus, Inc.
20310 SW 48th St.
South West Ranches,  FL  33332
Applicant Contact JOHN GREENBAUM
Correspondent
Cardiofocus, Inc.
20310 SW 48th St.
South West Ranches,  FL  33332
Correspondent Contact JOHN GREENBAUM
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/25/2001
Decision Date 03/18/2002
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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