Medical Device Manufacturer · US , Largo , FL

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

14 submissions · 14 cleared · Since 1994
14
Total
14
Cleared
0
Denied

Unilens Corp., USA — FDA 510(k) Products and Clearance History Ophthalmic

14 devices
1-14 of 14
Cleared Oct 30, 2014
CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
K142851 · LPL
Ophthalmic · 30d
Cleared Oct 05, 2012
CVUE ADVANCED HYDRA VUE
K121652 · LPL
Ophthalmic · 122d
Cleared Apr 20, 2011
SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX...
K110452 · LPL
Ophthalmic · 63d
Cleared Oct 28, 2010
CVUE ADVANCED DEFINITIVE
K100456 · LPL
Ophthalmic · 253d
Cleared Sep 11, 2008
CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K082393 · LPL
Ophthalmic · 23d
Cleared Apr 13, 2005
AQUAFLEX 2 (TEFILCON) CONTACT LENS
K050743 · LPL
Ophthalmic · 23d
Cleared Jul 07, 2004
C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS
K041608 · LPL
Ophthalmic · 22d
Cleared Oct 17, 2000
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS
K002408 · LPL
Ophthalmic · 71d
Cleared Apr 10, 1996
POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960926 · LPL
Ophthalmic · 35d
Cleared Mar 28, 1996
FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960376 · LPL
Ophthalmic · 62d
Cleared Mar 28, 1996
SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960380 · LPL
Ophthalmic · 62d
Cleared Jul 07, 1994
UNILENS 38 SOFT ASPHERIC CONTACT LENS
K941836 · LPL
Ophthalmic · 85d
Cleared Jul 07, 1994
SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS
K942372 · LPL
Ophthalmic · 50d
Cleared Apr 12, 1994
BAYVUE (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K940777 · LPL
Ophthalmic · 49d
Filters
All14 Ophthalmic 14