K023045 is an FDA 510(k) clearance for the MICRORUPTER V. This device is classified as a Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla (Class II - Special Controls, product code LXS).
Submitted by Meridian AG (Thun, Bern, CH). The FDA issued a Cleared decision on September 26, 2002, 14 days after receiving the submission on September 12, 2002.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4392.
| 510(k) Number | K023045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2002 |
| Decision Date | September 26, 2002 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LXS - Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4392 |