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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namelaser, neodymium:yag, ophthalmic for posterior capsulotomy and cutting pupilla
Generic Namend:yag laser
Regulation Number886.4392
PMA NumberP840047
Date Received10/02/1984
Decision Date08/02/1985
Reclassified Date 03/31/1988
Product Code
LXS[ Registered Establishments with LXS ]
Docket Number 85M-0402
Notice Date 09/11/1985
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002