510(k) · Cleared
ClearedSynergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for Keratoconus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synergeyes · HQD Lens, Contact (Other Material) - Daily
Cleared on Nov 30, 2005 as substantially equivalent to K051035 (Synergeyes, 2005) and 3 other predicates after a 64-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Nov 30, 2005
- Review
- 64 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K943177 (1994). 8 ancestors in all, the oldest P870024 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 2 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 1 generation backK051035 Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact LensSynergeyes · 2005
- This deviceK052675 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 · cites it directly · 1 of its ownK142510 UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat…Synergeyes, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK160938 SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid…Synergeyes, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K060102Synergeyes PS Hybrid Contact LensSynergeyes, Inc. · 2006 · cites it directly2descendants
- K142510UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact…Synergeyes, Inc. · 2014 · cites it directly1descendant
- K160938SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −2 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −1 | K051035 | Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact Lens | Synergeyes | 2005 | — |
| 0 (this device) | K052675 | Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for… | Synergeyes | 2005 | — |
| +1 | K060102 | Synergeyes PS Hybrid Contact Lens | Synergeyes, Inc. | 2006 | — |
| +1 | K142510 | UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea… | Synergeyes, Inc. | 2014 | — |
| +2 | K160938 | SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily… | Synergeyes, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
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 HQD? 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 HQD device
- #1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K051035 | Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact LensSummary page 1…of 5.50mm to 7.70mm · with diameter of 14.50mm The lens material (paflufocon D hem-iberfilcon A) is identical to the predicate current material cleared under K051035. There are no differences to the chemical composition, formulation, manufacturing process, packaging and sterilization as describ… | 2005 |
| * | P840004/ | Saturn II (TM) (Synergicon a) Contact Lens A supplement to the PMA, as the summary prints it. | 1993 |
| * | P870024 | Fluoroperm RGP Contact LensesSummary page 2…(synergicon A) Mixed use Lens P840004/S7 App: 10/14/1993 * For the RGP Center Portion: Paragon Vision Sciences P870024/S36 and S43 App: 11/23/1993 and 4/13/2002… | 1987 |
| * | K940277 | Paflufocon a, B, C & DSummary page 2…P870024/S36 and S43 App: 11/23/1993 and 4/13/2002 K940277 Cleared: 5/9/1994 * For the Soft Skirt Portion: SynergEyes TM, Inc. K051035… | 1994 |
What descends from it? (3)
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K060102 (Synergeyes, Inc., 2006) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K051035.
How does its category compare?
All HQD devicesHQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQD
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HQD
80in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQD
2in 2025
MAUDE reports naming product code HQD, 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 | 4 | 78 | 0 | 6 |
| 2008 | 5 | 100 | 0 | 8 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 1 | — | 0 | 26 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 7 | 119 | 0 | 1 |
| 2017 | 9 | 66 | 0 | 3 |
| 2018 | 5 | 53 | 0 | 0 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 3 | 123 | 0 | 3 |
| 2022 | 3 | 29 | 0 | 3 |
| 2023 | 3 | 77 | 0 | 8 |
| 2024 | 5 | 80 | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
SynergEyes TM KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052675: Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for Keratoconus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052675
Report an extraction error
Are you the manufacturer?
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