510(k) · Cleared
ClearedSynergeyes Sig (Petrafocon a Hem-Larafilcon a) 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 May 20, 2009 as substantially equivalent to K051035 (Synergeyes, 2005) and 3 other predicates after a 140-day review. Its family tree reaches back 5 generations to 1981. 1 later device descends from it.
- Decided
- May 20, 2009
- Review
- 140 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to P810005 (1981). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 4 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 3 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 2 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 1 generation backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- This deviceK083921 Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact LensSynergeyes, Inc. · 2009
- 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 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −4 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −3 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −2 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −1 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| 0 (this device) | K083921 | Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens | Synergeyes, Inc. | 2009 | — |
| +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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1994 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 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? (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 2…y be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses. 4. Predicate device For Design: Predicate- K051035 SynergEyesTM A & M (paflufocon D hem-iberfilcon A) Hybrid Contact Lens The SynergEyesTM SiH (petrafocon A… | 2005 |
| * | K052560 | Biofinity (Comfilcon a) Soft Contact LensSummary page 2…rocess to join the center and the peripheral portions at the junction of the optic edge where itjoins the peripheral ring. For MaterialSimilarities: Predicate- K051035, K052560, K033919, K970746 The SynergEyes MT SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lens has a rigid gas permeable center op… | 2005 |
| * | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal DesignsSummary page 2…join the center and the peripheral portions at the junction of the optic edge where itjoins the peripheral ring. For MaterialSimilarities: Predicate- K051035, K052560, K033919, K970746 The SynergEyes MT SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lens has a rigid gas permeable center optic porti… | 2004 |
| * | K970746 | SEE3 (Lotrafilcon a) Soft Contact LensSummary page 2…center and the peripheral portions at the junction of the optic edge where itjoins the peripheral ring. For MaterialSimilarities: Predicate- K051035, K052560, K033919, K970746 The SynergEyes MT SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lens has a rigid gas permeable center optic portion which… | 1997 |
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 28 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K160938 (Synergeyes, Inc., 2016) has gone furthest, with 0 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. 2009, 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?
SynergEyes® SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, 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 astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00D. 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/K083921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083921: Synergeyes Sig (Petrafocon a Hem-Larafilcon a) 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/K083921
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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