PMA · Approved
ApprovedFluoroperm RGP Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperVision, Inc. · MWL Lens, Contact (Rigid Gas Permeable), Extended Wear
Approved on Dec 31, 1987 through premarket approval, which rests on the device’s own clinical evidence after a 225-day review. 7 later devices descend from it.
- Decided
- Dec 31, 1987
- Review
- 225 days
- Class
- Class III
- Product code
- MWL
- Recalls
- None
7 later devices descend from it, 4 citing it directly.
- This deviceP870024 Fluoroperm RGP Contact LensesCooperVision, Inc. · 1987
- Descendant · cites it directly · 5 of its ownK051035 Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact LensSynergeyes · 2005
- 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 · 2 generations on · 1 of its ownK083921 Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact LensSynergeyes, Inc. · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K051035Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact LensSynergeyes · 2005 · cites it directly5descendants
- 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
- K083921Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact LensSynergeyes, Inc. · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P870024 | Fluoroperm RGP Contact Lenses | CooperVision, Inc. | 1987 | — |
| +1 | K051035 | Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact Lens | Synergeyes | 2005 | — |
| +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 | — |
| +2 | K083921 | Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens | Synergeyes, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 MWL? 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? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051035 | Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact Lens | 2005 | 5 |
| K052675 | Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for Keratoconus | 2005 | 3 |
| K060102 | Synergeyes PS Hybrid Contact Lens | 2006 | 2 |
| K032256 | Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid Gas… | 2003 | 0 |
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, K051035 (Synergeyes, 2005) has gone furthest, with 5 descendants of its own.
How does its category compare?
All MWL devicesMWL Lens, Contact (Rigid Gas Permeable), Extended Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWL
Too few MWL 510(k)s in any year since 2007 to give a median.
Recalls per year · MWL
No recall names MWL since 2007.
Adverse event reports per year · MWL
1in 2025
MAUDE reports naming product code MWL, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 4 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P870024 · printed Nov 6, 2026
Cite this page
510(k) Report. “P870024: Fluoroperm RGP Contact Lenses.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P870024
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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