PMA P020050S023
- Device
- WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P020050
- Supplement
- S023
- Product code
- LZS
- Decision date
- 2016-11-21
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- Approval for the WaveLight EX500 Excimer Laser System and Allegretto Wave Eye-Q Excimer Laser System. These devices are indicated for use in Photorefractive Keratectomy (PRK) treatments for: 1) the reduction or elimination of up to -6.0 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -6.0 D of spherical component and up to -3.0 D of astigmatic component at the spectacle plane;2) patients who are 18 years of age or older; and 3) patients with documentation of a stable manifest refraction defined as <=0.5 D preoperative spherical equivalent shift over one year prior to surgery.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020050S023B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P020050
- Supplement
- S023
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2016-11-21
- Decision code
- APPR
- Date received
- 2015-07-20
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the WaveLight EX500 Excimer Laser System and Allegretto Wave Eye-Q Excimer Laser System. These devices are indicated for use in Photorefractive Keratectomy (PRK) treatments for: 1) the reduction or elimination of up to -6.0 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -6.0 D of spherical component and up to -3.0 D of astigmatic component at the spectacle plane;2) patients who are 18 years of age or older; and 3) patients with documentation of a stable manifest refraction defined as