Synergeyes, Inc. - FDA 510(k) Cleared Devices
Recent clearances: 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, SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens, UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Synergeyes, Inc. Ophthalmic ✕
9 devices
Cleared
Nov 15, 2016
SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact...
Ophthalmic
327d
Cleared
Aug 01, 2016
SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily...
Ophthalmic
119d
Cleared
Nov 19, 2014
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea...
Ophthalmic
72d
Cleared
Apr 18, 2012
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
Ophthalmic
135d
Cleared
May 20, 2009
SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
Ophthalmic
140d
Cleared
May 30, 2008
SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS
Ophthalmic
49d
Cleared
Mar 05, 2008
SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR
Ophthalmic
40d
Cleared
Jun 22, 2006
SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES
Ophthalmic
62d
Cleared
Mar 15, 2006
SYNERGEYES PS HYBRID CONTACT LENS
Ophthalmic
61d