CONSTELLATION VISION SYSTEM
FDA 510(k) clearance K101285 · decided 2010-11-12
Clearance details
- K-number
- K101285
- Device name
- CONSTELLATION VISION SYSTEM
- Applicant
- Alcon Manufacturing, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-07
- Decision date
- 2010-11-12
- Days to decision
- 189 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 |
|---|---|---|
| Constellation Vision System, REF: 8065751150 recall (Z-0099-2024) | Alcon Research, LLC | 2023-10-11 |