PMA P970056
- Device
- BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
- Applicant
- Technolas GmbH Perfect Vision
- PMA number
- P970056
- Product code
- LZS
- Decision date
- 1999-09-28
- Generic name
- Excimer laser system
- 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P970056B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record
- Device
- BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
- Applicant
- Technolas GmbH Perfect Vision
- PMA number
- P970056
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 1999-09-28
- Decision code
- APWD
- Date received
- 1997-11-13
- 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.