WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
FDA premarket approval P020050/S023 · decided 2016-11-21
Approval details
- PMA number
- P020050
- Supplement
- S023
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2015-07-20
- Decision date
- 2016-11-21
- Days to decision
- 490 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the WaveLight EX500 Excimer Laser System and Allegretto Wave Eye-Q Excimer Laser System. These devices are indicated for use in Photorefractive Keratectomy (PRK) treatments for: 1) the reduction or elimination of up to -6.0 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -6.0 D of spherical component and up to -3.0 D of astigmatic component at the spectacle plane;2) patients who are 18 years of age or older; and 3) patients with documentation of a
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510(k) clearances by this applicant
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| 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 |