The following data is part of a premarket notification filed by Unilens Corp., Usa with the FDA for Sof-form Ii, Unilens, Unisite, Simulvue, Aquaflex, Ll-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue 38 Llbi 2,.
| Device ID | K110452 |
| 510k Number | K110452 |
| Device Name: | SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | UNILENS CORP., USA 10431 72ND ST. NORTH Largo, FL 33777 |
| Contact | Alan J Frazer |
| Correspondent | Alan J Frazer UNILENS CORP., USA 10431 72ND ST. NORTH Largo, FL 33777 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-16 |
| Decision Date | 2011-04-20 |