WAVELIGHT EX500 LASER SYSTEM, ALLEGRO ANALYZER
FDA premarket approval P020050/S011 · decided 2013-04-12
Approval details
- PMA number
- P020050
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WAVELIGHT EX500 LASER SYSTEM, ALLEGRO ANALYZER
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2013-01-18
- Decision date
- 2013-04-12
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL TO INTRODUCE THE WAVENET¿ NETWORK SYSTEM TO FACILITATE DATA EXCHANGE BETWEEN FDA APPROVED/ CLEARED WAVELIGHT® REFRACTIVE/ THERAPEUTIC AND DIAGNOSTIC DEVICES VIA A NETWORK SERVER.
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510(k) clearances by this applicant
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| UNITY VCS (8065000296); UNITY CS (8065000297) (K233876) | Alcon Laboratories, Inc. | 2024-06-21 |
| Centurion™ Vision System (Active Sentry™) (8065753057) (K233902) | Alcon Laboratories, Inc. | 2024-01-10 |
| Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856) | Alcon Laboratories, Inc. | 2023-12-29 |