510(k) · Cleared
ClearedSynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear 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 Aug 1, 2016 as substantially equivalent to K083921 (Synergeyes, Inc., 2009) and 3 other predicates after a 119-day review. Its family tree reaches back 8 generations to 1981.
- Decided
- Aug 1, 2016
- Review
- 119 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to P810005 (1981). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 7 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 6 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 5 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 4 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 3 generations backK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
- 2 generations backK142641 Intelliwave4Art Optical Contact Lens, Inc. · 2015
- 1 generation backK152046 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact…Art Optical Contact Lens, Inc. · 2015
- This deviceK160938 SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid…Synergeyes, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −7 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −6 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −5 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −4 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −3 | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
| −2 | K142641 | Intelliwave4 | Art Optical Contact Lens, Inc. | 2015 | — |
| −1 | K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens… | Art Optical Contact Lens, Inc. | 2015 | — |
| 0 (this device) | 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 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K083921 | Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact LensSummary page 5…510(k) Submission: ~ New Technology ~ The SynergEyes® SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses— cleared under 510(k) K083921 and K113586—are modified to include Hydra-PEG Technology (HPT), which is a thin, polyethylene glycol (PEG)-based polyme… | 2009 |
| * | K113586 | Synergeyes Sih (Petrafocon a Hem-Larafilcon a) Hybrid Contact LensSummary page 5…ssion: ~ New Technology ~ The SynergEyes® SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses— cleared under 510(k) K083921 and K113586—are modified to include Hydra-PEG Technology (HPT), which is a thin, polyethylene glycol (PEG)-based polymer designed t… | 2012 |
| * | K142510 | UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact…Summary page 5…-reference predicate “UltraHealth® SiH (petrafocon A hem-larafilcon A)” By SynergEyes, Inc. 510(k) number; K142510 -reference predicate Device Description: The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is… | 2014 |
| * | K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Summary page 5…-primary predicate “IntelliWave4 with HPT (safrofilcon A)” by Art Optical Contact Lens, Inc. 510(k) number; K152046 -reference predicate “UltraHealth® SiH (petrafocon A hem-larafilcon A)” By Sy… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 5 of the 29 ancestors have a recall of any class.
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. 2016, 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?
The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses 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 +25.00 and -25.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D. The…
Read the full statement (283 words)
The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses 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 +25.00 and -25.00
D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D.
The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear 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 +25.00 and -25.00 Din eyes with irregular astigmatism
up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D.
The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are
indicated 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, non-diseased eyes with or
without presbyopia. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 Din eyes with
astigmatism or irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and
scheduled replacement. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using
only a chemical (not heat) 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/K160938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160938: SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160938
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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