Medical Device Manufacturer · US , Largo , FL

Unilens Corp., USA - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1994

Recent clearances: CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens, CVUE ADVANCED HYDRA VUE, SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,

View 14 510(k) Devices ↓

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Unilens Corp., USA Ophthalmic ✕

14 devices

1-12 of 14

Cleared Oct 30, 2014

CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens

Ophthalmic · 30d

Cleared Oct 05, 2012

CVUE ADVANCED HYDRA VUE

Ophthalmic · 122d

Cleared Apr 20, 2011

SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX...

Ophthalmic · 63d

Cleared Oct 28, 2010

CVUE ADVANCED DEFINITIVE

Ophthalmic · 253d

Cleared Sep 11, 2008

CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

Ophthalmic · 23d

Cleared Apr 13, 2005

AQUAFLEX 2 (TEFILCON) CONTACT LENS

Ophthalmic · 23d

Cleared Jul 07, 2004

C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS

Ophthalmic · 22d

Cleared Oct 17, 2000

AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS

Ophthalmic · 71d

Cleared Apr 10, 1996

POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS

Ophthalmic · 35d

Cleared Mar 28, 1996

FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS

Ophthalmic · 62d

Cleared Mar 28, 1996

SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS

Ophthalmic · 62d

Cleared Jul 07, 1994

UNILENS 38 SOFT ASPHERIC CONTACT LENS

Ophthalmic · 85d