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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 K924588
Device Name ZEISS LASER INDIRECT OPHTHALMOSCOPE
Applicant
Carl Zeiss, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Applicant Contact CHRISTOPHER TALBOT
Correspondent
Carl Zeiss, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Correspondent Contact CHRISTOPHER TALBOT
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
GSB  
Date Received09/10/1992
Decision Date 07/09/1993
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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