Ocu-Ease Optical Products, Inc. - FDA 510(k) Cleared Devices
Recent clearances: OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR, TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ocu-Ease Optical Products, Inc. Ophthalmic ✕
9 devices
Cleared
Dec 10, 2002
OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR...
Ophthalmic
85d
Cleared
Apr 26, 2002
OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS
Ophthalmic
53d
Cleared
Jun 19, 2001
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND...
Ophthalmic
28d
Cleared
Feb 21, 2001
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT...
Ophthalmic
57d
Cleared
Feb 21, 2001
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B)...
Ophthalmic
57d
Cleared
Nov 08, 2000
OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B)...
Ophthalmic
47d
Cleared
Oct 04, 1999
OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR
Ophthalmic
73d
Cleared
Mar 25, 1996
TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS
Ophthalmic
63d
Cleared
Oct 13, 1994
OCU-FLEX-38 (POLYMACON)
Ophthalmic
171d