PMA · Approved
ApprovedSaturn II (TM) (Synergicon a) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wesley Jessen Corp. · HPX Lens, Contact (Polymethylmethacrylate)
Approved on Oct 14, 1993 through premarket approval, which rests on the device’s own clinical evidence after a 342-day review. 4 later devices descend from it.
- Decided
- Oct 14, 1993
- Review
- 342 days
- Class
- Class U
- Product code
- HPX
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceP840004/
S007 Saturn II (TM) (Synergicon a) Contact LensWesley Jessen Corp. · 1993 - Descendant · cites it directly · 3 of its ownK052675 Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens…Synergeyes · 2005
- Descendant · cites it directly · 2 of its ownK060102 Synergeyes PS Hybrid Contact LensSynergeyes, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK142510 UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat…Synergeyes, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK160938 SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid…Synergeyes, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K052675Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for KeratoconusSynergeyes · 2005 · cites it directly3descendants
- K060102Synergeyes PS Hybrid Contact LensSynergeyes, Inc. · 2006 · cites it directly2descendants
- K142510UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact…Synergeyes, Inc. · 2014 · 2 generations on1descendant
- K160938SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P840004/ | Saturn II (TM) (Synergicon a) Contact Lens | Wesley Jessen Corp. | 1993 | — |
| +1 | K052675 | Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for… | Synergeyes | 2005 | — |
| +1 | K060102 | Synergeyes PS Hybrid Contact Lens | Synergeyes, Inc. | 2006 | — |
| +2 | K142510 | UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea… | Synergeyes, Inc. | 2014 | — |
| +3 | K160938 | SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily… | Synergeyes, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HPX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K052675 (Synergeyes, 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HPX devicesHPX Lens, Contact (Polymethylmethacrylate): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HPX
FDA has decided no HPX device since 2007.
Median 510(k) review, days · HPX
Too few HPX 510(k)s in any year since 2007 to give a median.
Recalls per year · HPX
No recall names HPX since 2007.
Adverse event reports per year · HPX
1in 2017
MAUDE reports naming product code HPX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P840004/S007 · printed Nov 6, 2026
Cite this page
510(k) Report. “P840004/S007: Saturn II (TM) (Synergicon a) Contact Lens.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P840004/S007
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026