K191949 is an FDA 510(k) clearance for the UNFOLDER Vitan Inserter. This device is classified as a Folders And Injectors, Intraocular Lens (iol) (Class I - General Controls, product code MSS).
Submitted by Johnson & Johnson Surgical Vision, Inc. (Santa Ana, US). The FDA issued a Cleared decision on September 13, 2019, 53 days after receiving the submission on July 22, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300.
| 510(k) Number | K191949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2019 |
| Decision Date | September 13, 2019 |
| Days to Decision | 53 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 |