K984443 is an FDA 510(k) clearance for the ORBSCAN. This device is classified as a Device, Analysis, Anterior Segment (Class II - Special Controls, product code MXK).
Submitted by Technolas Perfect Vision GmbH (Anaheim Hills, US). The FDA issued a Cleared decision on March 5, 1999, 81 days after receiving the submission on December 14, 1998.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K984443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1998 |
| Decision Date | March 05, 1999 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MXK - Device, Analysis, Anterior Segment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |