The following data is part of a premarket notification filed by Visx, Incorporated with the FDA for Visx Customvue Slit Illuminator With Desktop Charger, Model Cv Si-1.
| Device ID | K043503 |
| 510k Number | K043503 |
| Device Name: | VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | VISX, INCORPORATED 3400 CENTRAL EXPRESSWAY Santa Clara, CA 95051 -0703 |
| Contact | Alan F Russell |
| Correspondent | Alan F Russell VISX, INCORPORATED 3400 CENTRAL EXPRESSWAY Santa Clara, CA 95051 -0703 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-04-05 |
| Summary: | summary |