One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
FDA 510(k) clearance K143434 · decided 2015-05-06
Clearance details
- K-number
- K143434
- Device name
- One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
- Applicant
- Abbott Medical Optics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-01
- Decision date
- 2015-05-06
- Days to decision
- 156 days
- Clearance type
- Abbreviated
- Product code
- MSS
- Device class
- 1
- Regulation number
- 886.4300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Santa Ana, CA, 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 |
|---|---|---|
| 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 |