BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P860040 S015

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.

Pre-market Approval Supplement Details

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.

DeviceBIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantWAVETOUCH TECHNOLOGIES, LLC
Date Received1998-05-19
Decision Date1999-03-04
PMAP860040
SupplementS015
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address WAVETOUCH TECHNOLOGIES, LLC 15970 Bernardo Center Dr. san Diego, CA 92127

Supplemental Filings

Supplement NumberDateSupplement Type
P860040Original 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

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