# K060102: Synergeyes PS Hybrid Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Synergeyes, Inc.
- Decided: Mar 15, 2006 after 61 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: 4 generations back to K943177 (1994). 9 ancestors in all.
2 later devices descend from it; 1 cites 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.
- K052675: Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for Keratoconus, 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
- 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
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. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 in eyes with astigmatism or irregular astigmatism up to 6.00D. 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/K060102
Methodology: https://510kreport.com/methodology