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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameVISULAS ND:YAG LASER
Classification Namelaser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
ApplicantCARL ZEISS, INC.
PMA NumberP850083
Supplement NumberS004
Date Received11/14/1986
Decision Date03/31/1987
Product Code
LOI
Docket Number 87M-0138
Notice Date 05/13/1987
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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