510(k) · Cleared
ClearedVarilux Visionprint System (VPS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Essilor Intl. · HLL Monitor, Eye Movement
Cleared on Jul 2, 2004 as substantially equivalent to K902954 (Permobil AB, 1990) after a 196-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jul 2, 2004
- Review
- 196 days
- Class
- Class II
- Product code
- HLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902954 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902954 OBER2 Monitor, Eye Movement (Ophthalmic)Permobil AB · 1990
- This deviceK033949 Varilux Visionprint System (VPS)Essilor Intl. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902954 | OBER2 Monitor, Eye Movement (Ophthalmic) | Permobil AB | 1990 | — |
| 0 (this device) | K033949 | Varilux Visionprint System (VPS) | Essilor Intl. | 2004 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HLL device
- #1 K222484 Retitrackscore 5.6 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K902954 | OBER2 Monitor, Eye Movement (Ophthalmic)Summary page 1…Classification Name: Eye Movement Monitor (see 21 C.F.R. § 886.1510) Product Code: HLL Predicate Device: OBER2 Eye Movement Monitor, 510(k) # K902954 Device Description: The VPS is a non-invasive ultrasonic device intended to measure the pattern… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K902954.
How does its category compare?
All HLL devicesHLL Monitor, Eye Movement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HLL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · HLL
Too few HLL 510(k)s in any year since 2007 to give a median.
Recalls per year · HLL
No recall names HLL since 2007.
Adverse event reports per year · HLL
No MAUDE report names HLL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral visual stimulus, to use as a guide for prescribing progressive power eyeglass lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033949: Varilux Visionprint System (VPS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033949
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026