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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 K894393
Device Name OPMILAS CO2-L
Applicant
Carl Zeiss, Inc.
One Zeiss Dr.
Thornwood,  NY  10594
Applicant Contact VAN CADER
Correspondent
Carl Zeiss, Inc.
One Zeiss Dr.
Thornwood,  NY  10594
Correspondent Contact VAN CADER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/17/1989
Decision Date 07/27/1989
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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