PMA P970005
- Device
- KREMER LASER SYSTEM
- Applicant
- Lasersight Technologies, Inc.
- PMA number
- P970005
- Product code
- LZS
- Decision date
- 1998-07-30
- Generic name
- Excimer laser system
- Approval order statement
- Approval for a single laser, Kremer Excimer Laser System Serial No. KEA940202. This device, using a 6.0 mm ablation zone, is indicated for myopic and astigmatic laser in situ keratomileusis (LASIK) in patients: 1)with myopia ranging between -1.0 and -15.0 diopters (D) with or without astigmatism ranging from 0.0 D to 5.00 D; 2) who are 18 years of age or older; and 3) with stable refraction over the 1-year period prior to surgery. Note: Patients between 18 and 20 years old should not demonstrate a shift in refraction greater than 0.5D. Patients 21 years and older should not demonstrate a shift greater than 1.0 D.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P970005B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- KREMER LASER SYSTEM
- Applicant
- Lasersight Technologies, Inc.
- PMA number
- P970005
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 1998-07-30
- Decision code
- APPR
- Date received
- 1997-01-31
- Approval order statement
- Approval for a single laser, Kremer Excimer Laser System Serial No. KEA940202. This device, using a 6.0 mm ablation zone, is indicated for myopic and astigmatic laser in situ keratomileusis (LASIK) in patients: 1)with myopia ranging between -1.0 and -15.0 diopters (D) with or without astigmatism ranging from 0.0 D to 5.00 D; 2) who are 18 years of age or older; and 3) with stable refraction over the 1-year period prior to surgery. Note: Patients between 18 and 20 years old should not demonstrate a shift in refraction greater than 0.5D. Patients 21 years and older should not demonstrate a shift greater than 1.0 D.