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.
Approval for a toric configuration of the biocurve soft fw (methafilcon a) contact lens (clear and handling tint). The device, as modified, will be marketed under the trade name biocurve soft toric fw (methafilcon a) contact lens and is indicated for daily wear or extended wear by not-aphakic persons with non-diseased eyes. The lenses are for the correct of refractive ametropia (myopia, hyperopia, and astigmatism). The spherical lens may be worn by persons with up to 1. 50 diopters of astigmatism that does not interfere with visual acuity; the toric lens corrects astigmatism of 5 diopters or less. Lenses prescribed for extended wear may be worn from 1 to 7 days between removals for cleaning, rinsing, and disinfection or replacement, as recommended by the eyecare practitioner. The lenses may be disinfected using a chemical disinfection system only.
| Device | BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | WAVETOUCH TECHNOLOGIES, LLC |
| Date Received | 1998-05-19 |
| Decision Date | 1999-03-04 |
| PMA | P860040 |
| Supplement | S015 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | WAVETOUCH TECHNOLOGIES, LLC 15970 Bernardo Center Dr. san Diego, CA 92127 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860040 | Original Filing | |
| S016 | 2004-05-05 | Normal 180 Day Track No User Fee |
| S015 | 1998-05-19 | Normal 180 Day Track |
| S014 | 1997-04-01 | Normal 180 Day Track |
| S013 | 1995-02-28 | Normal 180 Day Track |
| S012 | 1993-04-28 | Normal 180 Day Track |
| S011 | 1992-01-23 | Normal 180 Day Track |
| S010 | 1991-08-27 | Normal 180 Day Track |
| S009 | 1990-09-17 | Normal 180 Day Track |
| S008 | 1990-09-04 | Normal 180 Day Track |
| S007 | 1989-08-28 | Normal 180 Day Track |
| S006 | 1989-06-19 | Normal 180 Day Track |
| S005 | ||
| S004 | 1989-06-01 | Normal 180 Day Track |
| S003 | 1989-03-14 | Normal 180 Day Track |
| S002 | 1987-07-02 | Normal 180 Day Track |
| S001 | 1987-02-10 | Normal 180 Day Track |