ALCON VISION SYSTEM
FDA 510(k) clearance K063583 · decided 2008-05-09
Clearance details
- K-number
- K063583
- Device name
- ALCON VISION SYSTEM
- Applicant
- Alcon
- Decision
- Substantially Equivalent
- Date received
- 2006-11-30
- Decision date
- 2008-05-09
- Days to decision
- 526 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Silikon 1000 (P950008/S023) | Alcon | 2024-06-03 |
| Silikon 1000 (P950008/S022) | Alcon | 2023-10-20 |
| Silikon 1000 (P950008/S019) | Alcon | 2023-09-15 |
| Silikon 1000 (P950008/S016) | Alcon | 2023-08-02 |
| Silikon 1000 (P950008/S021) | Alcon | 2023-06-26 |
| Silikon 1000 (P950008/S018) | Alcon | 2023-04-20 |
| Silikon 1000 (P950008/S017) | Alcon | 2023-02-22 |
| Silikon 1000 (P950008/S015) | Alcon | 2021-02-15 |