K143434 is an FDA 510(k) clearance for the One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series. This device is classified as a Folders And Injectors, Intraocular Lens (iol) (Class I - General Controls, product code MSS).
Submitted by Abbott Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on May 6, 2015, 156 days after receiving the submission on December 1, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300.
| 510(k) Number | K143434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2014 |
| Decision Date | May 06, 2015 |
| Days to Decision | 156 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MSS — Folders And Injectors, Intraocular Lens (iol) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4300 |