The following data is part of a premarket notification filed by Essilor Intl. with the FDA for Varilux Visionprint System (vps).
| Device ID | K033949 |
| 510k Number | K033949 |
| Device Name: | VARILUX VISIONPRINT SYSTEM (VPS) |
| Classification | Monitor, Eye Movement |
| Applicant | ESSILOR INTL. 1301 K STREET, NW Washington, DC 20005 |
| Contact | Marc J Scheineson |
| Correspondent | Marc J Scheineson ESSILOR INTL. 1301 K STREET, NW Washington, DC 20005 |
| Product Code | HLL |
| CFR Regulation Number | 886.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-19 |
| Decision Date | 2004-07-02 |
| Summary: | summary |