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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 K883089
Device Name 4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02
Applicant
Heraeus Lasersonics, Inc.
3420 Central Expy.
P.O. Box 58005
Santa Clara,  CA  95051
Applicant Contact CHARLES L ROSE
Correspondent
Heraeus Lasersonics, Inc.
3420 Central Expy.
P.O. Box 58005
Santa Clara,  CA  95051
Correspondent Contact CHARLES L ROSE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/21/1988
Decision Date 09/28/1988
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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