This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Direct hydration of lenses.
| Device | SOF-FORM 55 EW, LL-55, SOFTCON EW 2 |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Unilens Corp., USA |
| Date Received | 2013-07-08 |
| Decision Date | 2013-08-06 |
| PMA | P890040 |
| Supplement | S007 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Unilens Corp., USA 10431 72nd St. North largo, FL 33777 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890040 | Original Filing | |
| S008 | 2016-02-04 | 30-day Notice |
| S007 | 2013-07-08 | 30-day Notice |
| S006 | 2007-12-31 | 135 Review Track For 30-day Notice |
| S005 | 1998-11-04 | Normal 180 Day Track |
| S004 | 1991-11-25 | Normal 180 Day Track |
| S003 | 1991-02-11 | Normal 180 Day Track |
| S002 | 1990-10-02 | Normal 180 Day Track |
| S001 | 1989-10-10 | Normal 180 Day Track |