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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 K881619
Device Name 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER
Applicant
Heraeus Lasersonics, Inc.
3420 Central Expy.
P.O. Box 58005
Santa Clara,  CA  95051
Applicant Contact LISA MCGRATH
Correspondent
Heraeus Lasersonics, Inc.
3420 Central Expy.
P.O. Box 58005
Santa Clara,  CA  95051
Correspondent Contact LISA MCGRATH
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/13/1988
Decision Date 07/08/1988
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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