# K081034: Synergeyes Hybrid Contact Lenses - Daily Wear, Models a, M, KC and PS

- Pathway: 510(k) (Abbreviated)
- Applicant: Synergeyes, Inc.
- Decided: May 30, 2008 after 49 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
SynergEyesTM A and M (paflufocon D hem-iberfilcon 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 astigmnatism tip to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses. SynergEyes T M KC (paflufocon D hem-iberfilcon A) Hybrid Contact lenses for keratoconis are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest 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 10.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses. SynergEyesT M PS (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmnatism, and irregular astigmatism 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 eyes with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

Source page: https://510kreport.com/device/K081034
Methodology: https://510kreport.com/methodology