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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 K884204
Device Name COHERENT EXCELITE CO2 AIR FIBER
Applicant
Coherent Medical Lasers
3270 W. Bayshore Rd.
P .O. Box 10122
Palo Alto,  CA  94303
Applicant Contact ALAN VOSS
Correspondent
Coherent Medical Lasers
3270 W. Bayshore Rd.
P .O. Box 10122
Palo Alto,  CA  94303
Correspondent Contact ALAN VOSS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/06/1988
Decision Date 11/03/1988
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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