Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
DeviceBAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantTECHNOLAS GMBH PERFECT VISION
PO BOX 17190
ANAHEIM HILLS, CA 92817
PMA NumberP970056
Date Received11/13/1997
Decision Date09/28/1999
Withdrawal Date 04/12/2012
Product Code LZS 
Docket Number 01M-0309
Notice Date 07/23/2001
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for 16 units of the KERACOR(R) 116 ophthalmic excimer laser system. This device is indicated for myopic photorefractive keratectomy (PRK) in patients who meet the following criteria: 1) In Photorefractive Keratectomy (PRK) treatments for the reduction or elimination of myopia between -1.50 to -7.00D of sphere and less than or equal to -4.5D of astigmatism. 2) In patients with documented evidence of a change in manifest refraction of less than or equal to 0.50 diopters (in both cylinder an sphere components) for at least one year prior to the date of the pre-operative examination. 3) In patients who are 18 yrs of age or older.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  
-
-