# K052675: Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for Keratoconus

- Pathway: 510(k) (Traditional)
- Applicant: Synergeyes
- Decided: Nov 30, 2005 after 64 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: 3 generations back to K943177 (1994). 8 ancestors in all.
3 later devices descend from it; 2 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)
- K051035: Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact Lens, Synergeyes (2005) Summary page 1.
- P840004/S007: Saturn II (TM) (Synergicon a) Contact Lens, Wesley Jessen Corp. (1993). A supplement to the PMA, as the summary prints it.
- P870024: Fluoroperm RGP Contact Lenses, CooperVision, Inc. (1987) Summary page 2.
- K940277: Paflufocon a, B, C & D, Paragon Vision Sciences (1994) Summary page 2.

## Most influential descendants
- 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
- 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 TM KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus 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 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/K052675
Methodology: https://510kreport.com/methodology