# K160938: SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens

- Pathway: 510(k) (Traditional)
- Applicant: Synergeyes, Inc.
- Decided: Aug 1, 2016 after 119 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to P810005 (1981). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083921: Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens, Synergeyes, Inc. (2009) Summary page 5.
- K113586: Synergeyes Sih (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens, Synergeyes, Inc. (2012) Summary page 5.
- K142510: UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens, Synergeyes, Inc. (2014) Summary page 5.
- K152046: Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A), Art Optical Contact Lens, Inc. (2015) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K160938
Methodology: https://510kreport.com/methodology