Company ยท US
Synergeyes, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2016. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | 11 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2016 | K153714 | SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilco Synergeyes, Inc. | HQD |
| Aug 1, 2016 | K160938 | SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens Synergeyes, Inc. | HQD |
| Nov 19, 2014 | K142510 | UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens Synergeyes, Inc. | HQD |
| Apr 18, 2012 | K113586 | SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS Synergeyes, Inc. | HQD |
| May 20, 2009 | K083921 | SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS Synergeyes, Inc. | HQD |
| May 30, 2008 | K081034 | SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS Synergeyes, Inc. | HQD |
| Mar 5, 2008 | K080193 | SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR Synergeyes, Inc. | HQD |
| Jun 22, 2006 | K061120 | SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES Synergeyes, Inc. | HQD |
| Mar 15, 2006 | K060102 | SYNERGEYES PS HYBRID CONTACT LENS Synergeyes, Inc. | HQD |
| Nov 30, 2005 | K052675 | SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS Synergeyes | HQD |
| Sep 2, 2005 | K051035 | SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS Synergeyes | HQD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||