The following data is part of a premarket notification filed by Nidek Technologies Srl with the FDA for Confoscan 2 Confocal Microscope.
| Device ID | K012416 |
| 510k Number | K012416 |
| Device Name: | CONFOSCAN 2 CONFOCAL MICROSCOPE |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | NIDEK TECHNOLOGIES SRL 21911 ERIE LN. Lake Forest, CA 92630 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson NIDEK TECHNOLOGIES SRL 21911 ERIE LN. Lake Forest, CA 92630 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-30 |
| Decision Date | 2001-10-26 |
| Summary: | summary |