K101134 is an FDA 510(k) clearance for the VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430. This device is classified as a Folders And Injectors, Intraocular Lens (iol) (Class I - General Controls, product code MSS).
Submitted by Medicel AG (Monrovia, US). The FDA issued a Cleared decision on August 9, 2010, 109 days after receiving the submission on April 22, 2010.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300.
| 510(k) Number | K101134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2010 |
| Decision Date | August 09, 2010 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| 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 |