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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 K885181
Device Name (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2
Applicant
Heraeus Lasersonics, Inc.
3420 Central Expy.
P.O. Box 58005
Santa Clara,  CA  95051
Applicant Contact DONNA PAGE
Correspondent
Heraeus Lasersonics, Inc.
3420 Central Expy.
P.O. Box 58005
Santa Clara,  CA  95051
Correspondent Contact DONNA PAGE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/14/1988
Decision Date 01/10/1989
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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