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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLASERVISION/VISX EXCIMER LASER MODEL C
Generic NameExcimer laser system
ApplicantLASER VISION CENTERS, INC.
540 MARYVILLE CENTRE DR., #200
ST. LOUIS, MO 63141
PMA NumberP960019
Date Received06/03/1996
Decision Date11/15/1996
Withdrawal Date 02/26/2002
Product Code LZS 
Docket Number 97M-0256
Notice Date 07/23/1997
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
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 
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