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
265–288 of 486
Cleared Mar 29, 1999
RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T
K983496
Opti-Centre Laboratories
Ophthalmic · 175d
Cleared Mar 15, 1999
TETRAFILCON A
K990606
CooperVision, Inc.
Ophthalmic · 20d
Cleared Feb 18, 1999
ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR
K983160
Hydron , Ltd.
Ophthalmic · 162d
Cleared Feb 16, 1999
IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS
K984523
Igel Vision Care Pte , Ltd.
Ophthalmic · 57d
Cleared Jan 29, 1999
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS
K982947
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 161d
Cleared Jan 26, 1999
VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER
K983912
Vistakon, Johnson & Johnson Vision Products, Inc.
Ophthalmic · 84d
Cleared Jan 21, 1999
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS
K984046
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 70d
Cleared Jan 21, 1999
PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
K984259
Cl-Tinters
Ophthalmic · 52d
Cleared Jan 20, 1999
FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER)
K982997
Aspect Vision Care, Ltd.
Ophthalmic · 146d
Cleared Jan 06, 1999
PRECISION UV (VASURFILCON A)
K982988
Wesley Jessen Corp.
Ophthalmic · 133d
Cleared Dec 22, 1998
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS
K982344
Wesley Jessen Corp.
Ophthalmic · 169d
Cleared Dec 22, 1998
BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
K983773
Benz Research and Development Corp.
Ophthalmic · 57d
Cleared Nov 25, 1998
OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)
K983278
Alden Optical Labs., Inc.
Ophthalmic · 69d
Cleared Nov 18, 1998
BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
K983894
Bausch & Lomb, Inc.
Ophthalmic · 15d
Cleared Nov 13, 1998
METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC
K983021
Metrosoft, Inc.
Ophthalmic · 74d
Cleared Nov 06, 1998
POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
K982110
Optech, Inc.
Ophthalmic · 143d
Cleared Oct 21, 1998
ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)
K983053
Alden Optical Labs., Inc.
Ophthalmic · 50d
Cleared Sep 02, 1998
SOFT (HYDROPHILIC) CONTACT LENSES
K982774
Cl-Tinters
Ophthalmic · 26d
Cleared Sep 01, 1998
ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS
K982904
Les Laboratoires Blanchard
Ophthalmic · 14d
Cleared Jul 06, 1998
IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
K974837
Igel Vision Care Pte , Ltd.
Ophthalmic · 194d
Cleared Jun 24, 1998
CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT
K981779
Cantor & Silver , Ltd.
Ophthalmic · 35d
Cleared Jun 23, 1998
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)
K981252
Alden Optical Labs., Inc.
Ophthalmic · 78d
Cleared May 13, 1998
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS
K980649
CooperVision, Inc.
Ophthalmic · 83d
Cleared Apr 22, 1998
FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
K980634
Aspect Vision Care, Ltd.
Ophthalmic · 62d