K062895 is an FDA 510(k) clearance for the XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII. This device is classified as a Endoilluminator (Class II - Special Controls, product code MPA).
Submitted by Dutch Ophthalmic Research Center International BV (Kingston, US). The FDA issued a Cleared decision on October 13, 2006, 16 days after receiving the submission on September 27, 2006.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K062895 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2006 |
| Decision Date | October 13, 2006 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MPA — Endoilluminator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |