INFINITI(R) VISION SYSTEM
FDA 510(k) clearance K120912 · decided 2012-06-15
Clearance details
- K-number
- K120912
- Device name
- INFINITI(R) VISION SYSTEM
- Applicant
- Alcon Manufacturing, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-03-26
- Decision date
- 2012-06-15
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE. Model recall (Z-0506-2015) | Alcon Research, Ltd. | 2014-12-04 |