INFINITI
FDA 510(k) clearance K021566 · decided 2002-07-02
Clearance details
- K-number
- K021566
- Device name
- INFINITI
- Applicant
- Alcon Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-13
- Decision date
- 2002-07-02
- Days to decision
- 50 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
| Record | Firm | Date |
|---|---|---|
| Infinity FMS Pak recall (Z-2408-2023) | Alcon Research, LTD. | 2023-08-16 |
| LAUREATE World Phaco System recall (Z-2834-2016) | Alcon Research, Ltd. | 2016-09-15 |
| INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, recall (Z-1597-2016) | Alcon Research, Ltd. | 2016-05-03 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S159) | Alcon Laboratories, Inc. | 2025-12-12 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S158) | Alcon Laboratories, Inc. | 2025-09-18 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S157) | Alcon Laboratories, Inc. | 2025-08-25 |
| AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (P930014/S152) | Alcon Laboratories, Inc. | 2025-06-18 |
| AcrySof Posterior Chamber Intraocular Lenses (P930014/S154) | Alcon Laboratories, Inc. | 2025-03-21 |
| WaveLight EX500 Laser (P020050/S043) | Alcon Laboratories, Inc. | 2025-03-05 |
| AcrySof Posterior Chamber Intraocular Lens (IOL) (P930014/S155) | Alcon Laboratories, Inc. | 2025-02-14 |
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S153) | Alcon Laboratories, Inc. | 2025-02-04 |