PMA P860040S015

Device: BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
Applicant: Wavetouch Technologies, LLC
PMA number: P860040
Supplement: S015
Product code: LPM
Decision date: 1999-03-04
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: 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.

Current openFDA PMA Record#

Device: BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
Applicant: Wavetouch Technologies, LLC
PMA number: P860040
Supplement: S015
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1999-03-04
Decision code: APPR
Date received: 1998-05-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: 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.