Lenses, Soft Contact, Extended Wear
Basic Information
- Device Name
- Lenses, Soft Contact, Extended Wear
- Trade Name
- BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
- PMA Number
- P860040
- Supplement Number
- S015
- Device Class
- FDA Class 3
- Product Code
- LPM
- Generic Name
- Lenses, soft contact, extended wear
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 4, 1999
- Date Received
- May 19, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPM | Lenses, Soft Contact, Extended Wear | FDA class 3 | Ophthalmic |