WaveLight EX500 Laser System
FDA premarket approval P020050/S029 · decided 2018-05-11
Approval details
- PMA number
- P020050
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WaveLight EX500 Laser System
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2018-02-27
- Decision date
- 2018-05-11
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for Platform Enhancement Refractive Suite Phase I (PERS I) hardware changes (color concept, update to head-up display, keyboard, control panel and console updates), and include software release Green SP4 (SP = Service Pack) with changes to the graphical user interface.
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