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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 K897099
Device Name MODEL 2800 ND:YAG OPHTHALMIC LASER
Applicant
Alcon Surgical, Inc.
17701 Cowan Ave.
Irvine,  CA  92713
Applicant Contact DAVE KRAPF
Correspondent
Alcon Surgical, Inc.
17701 Cowan Ave.
Irvine,  CA  92713
Correspondent Contact DAVE KRAPF
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/21/1989
Decision Date 02/16/1990
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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