SOFT-FORM 55EW; LL-55; SOFTCON EW2
FDA premarket approval P890040/S008 · decided 2016-02-29
Approval details
- PMA number
- P890040
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOFT-FORM 55EW; LL-55; SOFTCON EW2
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Unilens Corp., USA
- Date received
- 2016-02-04
- Decision date
- 2016-02-29
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Clearwater, FL
- Statement
- Increase to the sterilization load size to utilize more of the chamber capacity.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens (K142851) | Unilens Corp., USA | 2014-10-30 |
| CVUE ADVANCED HYDRA VUE (K121652) | Unilens Corp., USA | 2012-10-05 |
| SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, (K110452) | Unilens Corp., USA | 2011-04-20 |
| CVUE ADVANCED DEFINITIVE (K100456) | Unilens Corp., USA | 2010-10-28 |
| CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS (K082393) | Unilens Corp., USA | 2008-09-11 |
| AQUAFLEX 2 (TEFILCON) CONTACT LENS (K050743) | Unilens Corp., USA | 2005-04-13 |
| C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS (K041608) | Unilens Corp., USA | 2004-07-07 |
| AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS (K002408) | Unilens Corp., USA | 2000-10-17 |