Company ยท US
Unilens Corp., USA
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2014. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 14 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 30, 2014 | K142851 | CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens Unilens Corp., USA | LPL |
| Oct 5, 2012 | K121652 | CVUE ADVANCED HYDRA VUE Unilens Corp., USA | LPL |
| Apr 20, 2011 | K110452 | SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, Unilens Corp., USA | LPL |
| Oct 28, 2010 | K100456 | CVUE ADVANCED DEFINITIVE Unilens Corp., USA | LPL |
| Sep 11, 2008 | K082393 | CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS Unilens Corp., USA | LPL |
| Apr 13, 2005 | K050743 | AQUAFLEX 2 (TEFILCON) CONTACT LENS Unilens Corp., USA | LPL |
| Jul 7, 2004 | K041608 | C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS Unilens Corp., USA | LPL |
| Oct 17, 2000 | K002408 | AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS Unilens Corp., USA | LPL |
| Apr 10, 1996 | K960926 | POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS Unilens Corp., USA | LPL |
| Mar 28, 1996 | K960380 | SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS Unilens Corp., USA | LPL |
| Mar 28, 1996 | K960376 | FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS Unilens Corp., USA | LPL |
| Jul 7, 1994 | K942372 | SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS Unilens Corp., USA | LPL |
| Jul 7, 1994 | K941836 | UNILENS 38 SOFT ASPHERIC CONTACT LENS Unilens Corp., USA | LPL |
| Apr 12, 1994 | K940777 | BAYVUE (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS Unilens Corp., USA | LPL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||