510(k) K033949
K033949 is an FDA 510(k) premarket notification submitted by Essilor Intl. for the device "VARILUX VISIONPRINT SYSTEM (VPS)". The FDA issued a decision of Substantially Equivalent on Jul 2, 2004. The device falls under product code HLL (Monitor, Eye Movement), a Class II device regulated under 21 CFR 886.1510. Essilor Intl. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 2, 2004
- Date Received
- Dec 19, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Eye Movement
- Device Class
- Class II
- Regulation Number
- 886.1510
- Review Panel
- OP
- Submission Type
- 510(k)