WAVELIGHT EX500 LASER SYSTEM
FDA premarket approval P030008/S019 · decided 2015-06-02
Approval details
- PMA number
- P030008
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WAVELIGHT EX500 LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2015-02-27
- Decision date
- 2015-06-02
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028) THE DEVICES, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAMES WAVELIGHT® EX500 EXCIMER LASER SYSTEM - EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028).
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