K112977 is an FDA 510(k) clearance for the MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4). This device is classified as a Folders And Injectors, Intraocular Lens (iol) (Class I - General Controls, product code MSS).
Submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on March 27, 2012, 173 days after receiving the submission on October 6, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300.
| 510(k) Number | K112977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2011 |
| Decision Date | March 27, 2012 |
| Days to Decision | 173 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 |