WaveLight EX500 Laser
FDA premarket approval P030008/S031 · decided 2020-08-21
Approval details
- PMA number
- P030008
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WaveLight EX500 Laser
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2020-02-25
- Decision date
- 2020-08-21
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for software changes on the WaveLight® EX500 and the associated WaveNet Planning Software (WPS) to include enhanced WaveFront Optimized (eWFO) treatment with finer adjustment steps for targeted refraction and targeted optical zone.
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