LPL · Class II · 21 CFR 886.5925

FDA Product Code LPL: Lenses, Soft Contact, Daily Wear

Under FDA product code LPL, soft contact lenses for daily wear are cleared for the correction of refractive errors including myopia, hyperopia, and astigmatism.

These hydrophilic lenses conform to the shape of the cornea and correct vision by refracting light onto the retina. Daily wear lenses are removed nightly for cleaning and disinfection, distinguishing them from extended wear lenses cleared under other product codes.

LPL devices are Class II medical devices, regulated under 21 CFR 886.5925 and reviewed by the FDA Ophthalmic panel.

Leading manufacturers include CooperVision, Inc., Alcon Laboratories, Inc. and Ciba Vision Corporation.

486
Total
486
Cleared
116d
Avg days
1994
Since
486 devices
337–360 of 486
Cleared Aug 23, 1996
BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT
K961103
Benz Research and Development Corp.
Ophthalmic · 156d
Cleared May 21, 1996
SOFT-55 DAILY WEAR CONTACT LENS
K961428
Lombart Lenses, Ltd.
Ophthalmic · 36d
Cleared Apr 11, 1996
FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS
K950294
Flexlens, Inc.
Ophthalmic · 442d
Cleared Apr 10, 1996
POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960926
Unilens Corp., USA
Ophthalmic · 35d
Cleared Mar 28, 1996
W-55 (METHAFILON A) CONTACT LENS
K954524
Westcon Contact Lens Co., Inc.
Ophthalmic · 181d
Cleared Mar 28, 1996
FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960376
Unilens Corp., USA
Ophthalmic · 62d
Cleared Mar 28, 1996
SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960380
Unilens Corp., USA
Ophthalmic · 62d
Cleared Mar 25, 1996
TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS
K960291
Ocu-Ease Optical Products, Inc.
Ophthalmic · 63d
Cleared Feb 14, 1996
DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K953807
Stephen A. Dunn, Inc.
Ophthalmic · 190d
Cleared Jan 04, 1996
DURASOFT FRESHLOOK UV COLORS
K954603
Wesley Jessen Corp.
Ophthalmic · 92d
Cleared Nov 24, 1995
AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K954139
CooperVision, Inc.
Ophthalmic · 84d
Cleared Jul 25, 1995
TETRAFILCON A HYDROPHILIC CONTACT LENSES
K950968
CooperVision, Inc.
Ophthalmic · 146d
Cleared Dec 19, 1994
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
K944895
Bausch & Lomb, Inc.
Ophthalmic · 76d
Cleared Jun 09, 1994
DAILY WEAR SOFT CONTACT LENSES
K941484
Ciba Vision Corporation
Ophthalmic · 73d
Cleared May 27, 1994
BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS
K941370
Bausch & Lomb, Inc.
Ophthalmic · 66d