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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
PMA NumberP930016
Supplement NumberS010
Date Received06/18/1999
Decision Date10/18/2000
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 01M-0015
Notice Date 01/22/2001
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
These devices are indicated for photorefractive keratectomy (prk) treatments: in patients with documented evidence of a change in manifest refraction of less than or equal to 0. 5 d per year for at least one year prior to the date of pre-operative examination; and in patients 21 years of age or older for the reduction or elimination of naturally occurring hyperopia between +0. 5 and + 5. 0 d sphere at the spectacle plane with refractive astigmatism from +0. 5 to +4. 0 d with a maximum manifest refraction spherical equivalent (mrse) of +6. 0 d.
Approval Order Approval Order