# K113586: Synergeyes Sih (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens

- Pathway: 510(k) (Abbreviated)
- Applicant: Synergeyes, Inc.
- Decided: Apr 18, 2012 after 135 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K160938: SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens (2016), 0 descendants of its own

## Indications for use
Duette~A SiH (petrafocon A hem-larafilcan 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 not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may, be disinfected using only a chemical disinfecting system compatible with both hydroget and rigid gas permeable tenses.

Source page: https://510kreport.com/device/K113586
Methodology: https://510kreport.com/methodology