WaveLight EX500 Laser System/Allegro Topolyzer Vario
FDA premarket approval P030008/S030 · decided 2019-12-13
Approval details
- PMA number
- P030008
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WaveLight EX500 Laser System/Allegro Topolyzer Vario
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2019-09-16
- Decision date
- 2019-12-13
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for changes to the software for the Allegro Topolyzer VARIO Diagnostic System related to the graphic user interface (GUI), workflow processing and improvements of picture recognition by increasing resolution.
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