# K051035: Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Synergeyes
- Decided: Sep 2, 2005 after 133 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: 2 generations back to K943177 (1994). 6 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P870024: Fluoroperm RGP Contact Lenses, CooperVision, Inc. (1987) Summary page 2.
- K940277: Paflufocon a, B, C & D, Paragon Vision Sciences (1994) Summary page 2.
- K002845: Paflufocon C and E Daily Contact Lens, Paragon Vision Sciences (2000) Summary page 2.
- K000795: Rigid Gas Permeable Contact Lens, Polymer Technology (2000) Summary page 2.
- P840004: B&L (Synergicon a) Synercon (TM) Contact Lens, Wesley Jessen Corp.. FDA lists this PMA only through its supplements; the earliest we hold is P840004/S001 (Apr 18, 1985). Summary page 2.

## Most influential descendants
- K052675: Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for Keratoconus (2005), 3 descendants of its own
- K060102: Synergeyes PS Hybrid Contact Lens (2006), 2 descendants of its own
- K142510: UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens (2014), 1 descendant of its own
- K083921: Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens (2009), 1 descendant of its own
- K160938: SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens (2016), 0 descendants of its own

## Indications for use
SynergEyes® 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 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.

Source page: https://510kreport.com/device/K051035
Methodology: https://510kreport.com/methodology