HQD · Class II · 21 CFR 886.5916

FDA Product Code HQD: Lens, Contact (other Material) - Daily

Leading manufacturers include Acuity Polymers, Inc., Contamac, Ltd. and Menicon Co, Ltd..

118
Total
118
Cleared
109d
Avg days
1984
Since
118 devices
25–48 of 118
Cleared Sep 20, 2017
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
K172314
Art Optical Contact Lens, Inc.
Ophthalmic · 50d
Cleared Aug 16, 2017
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)
K171950
Visionary Optics, LLC
Ophthalmic · 48d
Cleared Aug 01, 2017
HEXA100 (hexafocon A) Daily Wear Contact Lenses
K171077
Contamac, Ltd.
Ophthalmic · 112d
Cleared Jul 17, 2017
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
K171404
Bausch & Lomb, Incorporated
Ophthalmic · 66d
Cleared Jun 02, 2017
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
K170001
Acuity Polymers, Inc.
Ophthalmic · 150d
Cleared May 31, 2017
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
K170007
Acuity Polymers, Inc.
Ophthalmic · 148d
Cleared Mar 24, 2017
Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens
K170335
Valley Contax, Inc.
Ophthalmic · 50d
Cleared Jan 18, 2017
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens
K163254
Acuity Polymers, Inc.
Ophthalmic · 58d
Cleared Dec 08, 2016
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
K162005
Acuity Polymers, Inc.
Ophthalmic · 141d
Cleared Nov 15, 2016
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
K153714
Synergeyes, Inc.
Ophthalmic · 327d
Cleared Aug 10, 2016
Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses
K161100
Contamac, Ltd.
Ophthalmic · 113d
Cleared Aug 01, 2016
SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens
K160938
Synergeyes, Inc.
Ophthalmic · 119d
Cleared Jul 25, 2016
BostonSight PD Prosthetic Device
K161461
Bostonsight
Ophthalmic · 60d
Cleared Apr 27, 2016
EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES
K152724
Advanced Vision Technologies
Ophthalmic · 218d
Cleared Feb 09, 2016
BostonSight IC Corneal Lens, BostonSight IC Scleral Lens
K153066
Boston Foundation For Sight
Ophthalmic · 110d
Cleared Nov 19, 2014
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens
K142510
Synergeyes, Inc.
Ophthalmic · 72d
Cleared Jun 28, 2012
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN
K120996
Paragon Vision Sciences
Ophthalmic · 87d
Cleared Apr 18, 2012
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
K113586
Synergeyes, Inc.
Ophthalmic · 135d
Cleared Feb 03, 2011
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K103561
Menicon Co, Ltd.
Ophthalmic · 59d
Cleared Oct 09, 2008
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES
K081178
Contamac, Ltd.
Ophthalmic · 167d
Cleared Sep 23, 2008
MENICON Z RIGID GAS PERMEABLE CONTACT LENS
K081443
Menicon Co, Ltd.
Ophthalmic · 124d
Cleared Feb 21, 2008
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
K073184
Bausch & Lomb, Inc.
Ophthalmic · 100d
Cleared Aug 15, 2007
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
K071266
Bausch & Lomb, Inc.
Ophthalmic · 100d
Cleared Aug 02, 2007
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
K071043
Bausch & Lomb, Inc.
Ophthalmic · 112d