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
145–168 of 486
Cleared May 19, 2000
METHAFILCON A
K001090
CooperVision, Inc.
Ophthalmic · 45d
Cleared Mar 06, 2000
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
K000384
CooperVision, Inc.
Ophthalmic · 28d
Cleared Mar 03, 2000
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
K994125
Bausch & Lomb, Inc.
Ophthalmic · 87d
Cleared Mar 15, 1999
TETRAFILCON A
K990606
CooperVision, Inc.
Ophthalmic · 20d
Cleared Nov 18, 1998
BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
K983894
Bausch & Lomb, Inc.
Ophthalmic · 15d
Cleared May 13, 1998
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS
K980649
CooperVision, Inc.
Ophthalmic · 83d
Cleared Mar 11, 1998
SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
K974780
Bausch & Lomb, Inc.
Ophthalmic · 79d
Cleared Dec 19, 1997
PREFERENCE 60 AND PREFERENCE 60 TORIC
K963013
CooperVision, Inc.
Ophthalmic · 507d
Cleared Aug 08, 1997
OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K972454
Bausch & Lomb, Inc.
Ophthalmic · 38d
Cleared May 09, 1997
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
K970746
Ciba Vision Corporation
Ophthalmic · 70d
Cleared Dec 17, 1996
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS
K962185
CooperVision, Inc.
Ophthalmic · 194d
Cleared Nov 27, 1996
DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS
K963487
Ciba Vision Corporation
Ophthalmic · 85d
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