COMPLETE BLINK-N-CLEAN LENS DROPS
FDA 510(k) clearance K040839 · decided 2004-10-19
Clearance details
- K-number
- K040839
- Device name
- COMPLETE BLINK-N-CLEAN LENS DROPS
- Applicant
- Advanced Medical Optics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-31
- Decision date
- 2004-10-19
- Days to decision
- 202 days
- Clearance type
- Abbreviated
- Product code
- MRC
- Device class
- 2
- Regulation number
- 886.5918
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CEEON ULTRAVIOLET LIGHT-ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) (P810055/S072) | Advanced Medical Optics, Inc. | 2008-07-02 |
| CEEON PMMA UV-LIGHT ABSORBING POSTERIOR CHAMBER (IOLS) (P810055/S071) | Advanced Medical Optics, Inc. | 2005-02-04 |
| CEEON SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (P940007/S006) | Advanced Medical Optics, Inc. | 2001-04-02 |
| MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS (P810055/S069) | Advanced Medical Optics, Inc. | 1999-12-03 |
| CEEON MODEL 912 FOLDABLE INTRAOCULAR LENS (P940007/S005) | Advanced Medical Optics, Inc. | 1999-07-30 |
| PERMAFLEX NATURALS (P790020/S059) | Advanced Medical Optics, Inc. | 1998-10-27 |
| SILICONE POSTERIOR CHAMBER INTRACULAR LENSES IOL MODEL 127(920) (P940007/S004) | Advanced Medical Optics, Inc. | 1998-09-29 |
| MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS (P810055/S070) | Advanced Medical Optics, Inc. | 1998-07-15 |