Unilens Corp., USA
Largo, FL, US
Unilens Corp., USA appears in FDA device records in Largo, FL. FDA records list 14 510(k) clearances between and , 24 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 24
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Unilens Corp., USA between 1994 and 2014. The busiest year on record is 1994, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1996 | 3 |
| 2000 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142851 | CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens | LPL | Substantially Equivalent | |
| K121652 | CVUE ADVANCED HYDRA VUE | LPL | Substantially Equivalent | |
| K110452 | SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, | LPL | Substantially Equivalent | |
| K100456 | CVUE ADVANCED DEFINITIVE | LPL | Substantially Equivalent | |
| K082393 | CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | |
| K050743 | AQUAFLEX 2 (TEFILCON) CONTACT LENS | LPL | Substantially Equivalent | |
| K041608 | C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS | LPL | Substantially Equivalent | |
| K002408 | AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS | LPL | Substantially Equivalent | |
| K960926 | POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | LPL | Substantially Equivalent | |
| K960380 | SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | LPL | Substantially Equivalent | |
| K960376 | FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | LPL | Substantially Equivalent | |
| K942372 | SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS | LPL | Substantially Equivalent | |
| K941836 | UNILENS 38 SOFT ASPHERIC CONTACT LENS | LPL | Substantially Equivalent | |
| K940777 | BAYVUE (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain