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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 Nameexcimer laser system
PMA NumberP960019
Date Received06/03/1996
Decision Date11/15/1996
Withdrawal Date 02/26/2002
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 97M-0256
Notice Date 07/23/1997
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Device indicated for: 1)ptk in patients w/decreased best corrected visual acuity and/or with disabling pain that are the result of superficial corneal epithelial irregularities or stromal scars in the anterior one-third of the cornea. The patients must have failed w/alternative treatment options. For safety, the immediate postoperative corneal thickness must not be less than 250 microns. Examples of those conditions that warrant ptk are: a)corneal scars & opacity (from trauma and inactive infections), b)dystrophies (reis-buckler's, granular and lattice), c)thygeson's superficial keratitis, d) irregular corneal surfaces associated w/filamentary keratitis and salzmann's nodular degeneration, e)residual band keratopathy after unsuccessful edta treatment, and, f)scars subsequent to previous (not concurrent) pterygium excision. 2)prk for a 6. 0 ablation zone in patients who are myopic and meet all of the following criteria: 1)1. 0 to 6. 0 diopters (d) of myopia with astigmatism of 2. 0 diopters; b)refractive change is within 0. 5d for one year prior to the laser treatment; and c)18 years of age or older.
Supplements: S001 S002