The following data is part of a premarket notification filed by Dutch Ophthalmic Research Center International Bv with the FDA for Xenon Brightstar Illumination System, Model 1266.xiii.
| Device ID | K062895 |
| 510k Number | K062895 |
| Device Name: | XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII |
| Classification | Endoilluminator |
| Applicant | DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV ONE LITTLE RIVER RD. Kingston, NH 03848 |
| Contact | F Carleton |
| Correspondent | F Carleton DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV ONE LITTLE RIVER RD. Kingston, NH 03848 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-27 |
| Decision Date | 2006-10-13 |
| Summary: | summary |