# Synergeyes, Inc.

- Location (FDA's records): Rockville, MD
- FDA decisions: 11 (2005–2016): 11 510(k) clearances
- Names in FDA's records: Synergeyes, Inc. (9); Synergeyes (2)
- Product codes: HQD (11)
- Predicates its devices cite: 24 (9 its own); citations of its devices by later devices: 9 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- CooperVision, Inc.: 4 (https://510kreport.com/company/coopervision)
- Paragon Vision Sciences: 4 (https://510kreport.com/company/paragon-vision-sciences)
- Ciba Vision Corporation: 2 (https://510kreport.com/company/ciba-vision)
- Polymer Technology Corp.: 1 (https://510kreport.com/company/polymer-technology)
- Art Optical Contact Lens, Inc.: 1 (https://510kreport.com/company/art-optical-contact-lens)

## Its most-cited devices
- K051035: Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact Lens (2005), cited by 3
- K052675: Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for Keratoconus (2005), cited by 2
- K060102: Synergeyes PS Hybrid Contact Lens (2006), cited by 1
- K113586: Synergeyes Sih (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens (2012), cited by 1
- K083921: Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens (2009), cited by 1
- K142510: UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens (2014), cited by 1

## Recent decisions
- K153714: SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co (Nov 15, 2016)
- K160938: SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens (Aug 1, 2016)
- K142510: UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens (Nov 19, 2014)
- K113586: Synergeyes Sih (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens (Apr 18, 2012)
- K083921: Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens (May 20, 2009)
- K081034: Synergeyes Hybrid Contact Lenses - Daily Wear, Models a, M, KC and PS (May 30, 2008)
- K080193: Synergeyes Hybrid Contact Lenses-Daily Wear (Mar 5, 2008)
- K061120: Synergeyes (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lenses (Jun 22, 2006)

Source page: https://510kreport.com/company/synergeyes
