510(k) · Cleared
ClearedUltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synergeyes, Inc. · HQD Lens, Contact (Other Material) - Daily
Cleared on Nov 19, 2014 as substantially equivalent to K052675 (Synergeyes, 2005) and 1 other predicate after a 72-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Nov 19, 2014
- Review
- 72 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K943177 (1994). 10 ancestors in all, the oldest P870024 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 4 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 3 generations backK051035 Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact LensSynergeyes · 2005
- 2 generations backK052675 Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens…Synergeyes · 2005
- 1 generation backK060102 Synergeyes PS Hybrid Contact LensSynergeyes, Inc. · 2006
- This deviceK142510 UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat…Synergeyes, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK160938 SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid…Synergeyes, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K160938SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −4 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −3 | K051035 | Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact Lens | Synergeyes | 2005 | — |
| −2 | K052675 | Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for… | Synergeyes | 2005 | — |
| −1 | K060102 | Synergeyes PS Hybrid Contact Lens | Synergeyes, Inc. | 2006 | — |
| 0 (this device) | K142510 | UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea… | Synergeyes, Inc. | 2014 | — |
| +1 | 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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K052675 | Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for KeratoconusSummary page 6…raHealth™ SiH Hybrid hem-iberfilcon A) Hybrid Contact A hem-larafilcon A) Hybrid Contact Lenses Lens for Keratoconus (K052675) for Keratoconus Contact Lens (K083921) Manufac… | 2005 |
| * | K060102 | Synergeyes PS Hybrid Contact LensSummary page 5…brid (RGP Center and soft skirt) reverse geometry designs were cleared for the predicate SynergEyes™ (paflufocon D-hem iberfilcon A) Hybrid Contact Lenses in K056275 and K060102. The new lenses, the UltraHealth™ SiH (petrafocon A hem-larafilcon A) hybrid contact lenses for keratoconus, and the UltraHealth™… | 2006 |
| † | K083921 | Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160938 | SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens | 2016 | 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K160938 (Synergeyes, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052675.
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. 2014, this device’s year, is highlighted.
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?
UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or 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. For…
Read the full statement (195 words)
UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or 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. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.
UltraHealth™ Flat Cornea SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic and not aphakic, nondiseased eyes, with or without presbyopia. 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. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142510: UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142510
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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