SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
FDA 510(k) clearance K111446 · decided 2011-12-21
Clearance details
- K-number
- K111446
- Device name
- SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
- Applicant
- Abbott Medical Optics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-24
- Decision date
- 2011-12-21
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Medical Optics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is recall (Z-1670-2013) | Abbott Medical Optics, Inc. | 2013-07-09 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HEALON D SODIUM HYALURONATE SOLUTION (P880031/S016) | Abbott Medical Optics, Inc. | 2009-02-18 |
| VITRAX/HEALON D SODIUM HYALURONATE SOLUTION OPHTHALMIC VISCOSURGICAL DEVICES (P880031/S015) | Abbott Medical Optics, Inc. | 2008-09-19 |
| HEALON D (P880031/S014) | Abbott Medical Optics, Inc. | 2008-08-22 |
| CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS (P960034/S002) | Abbott Medical Optics, Inc. | 2007-05-08 |
| CEEON HSM UV LIGHT ABSORBING PMMA ANTERIOR CHAMBER IOLS (P880070/S012) | Abbott Medical Optics, Inc. | 2007-05-08 |
| CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS) (P880070/S011) | Abbott Medical Optics, Inc. | 2005-02-04 |
| MODEL HSM65 UV ABSORBING PMMA ANTERIOR CHAMBER LENS (P880070/S010) | Abbott Medical Optics, Inc. | 2004-03-17 |
| POLYMETHYLMETHACRYLATE(PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (P960034/S001) | Abbott Medical Optics, Inc. | 2000-02-07 |