Wave Light EX500 Laser
FDA premarket approval P020050/S028 · decided 2018-04-09
Approval details
- PMA number
- P020050
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Wave Light EX500 Laser
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2018-01-05
- Decision date
- 2018-04-09
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for modification of the electronic circuit of VSE (Versorgungseinheit or supply unit) board in the WaveLight EX500 system by adding resistor-capacitor circuits to the switch transistors to reduce the starting currents and improve the reliability and life of the board.
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