OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION
FDA 510(k) clearance K981574 · decided 1998-07-06
Clearance details
- K-number
- K981574
- Device name
- OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION
- Applicant
- Alcon
- Decision
- Substantially Equivalent
- Date received
- 1998-05-04
- Decision date
- 1998-07-06
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- 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
No recalls on record reference this clearance.
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 |