WaveLight EX500 Excimer Laser System
FDA premarket approval P020050/S031 · decided 2018-10-26
Approval details
- PMA number
- P020050
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WaveLight EX500 Excimer Laser System
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2018-09-26
- Decision date
- 2018-10-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Internally source component assembly and testing services for the Model 1125 bed, in addition to externally sourcing this service from the external supplier.
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