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 Alcon Laboratories, Inc., Pegavision Corporation and CooperVision, Inc..

486
Total
486
Cleared
116d
Avg days
1994
Since
Growing category - 26 submissions in the last 2 years vs 20 in the prior period
Review times increasing: avg 162d recently vs 113d historically

FDA 510(k) Cleared Lenses, Soft Contact, Daily Wear Devices (Product Code LPL)

486 devices
1–24 of 486
Cleared May 29, 2026
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
K260507
INTEROJO, Inc.
Ophthalmic · 101d
Cleared May 21, 2026
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses
K253352
Pegavision Corporation
Ophthalmic · 233d
Cleared May 19, 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K261299
Pegavision Corporation
Ophthalmic · 29d
Cleared Apr 29, 2026
PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS
K253885
GEO MEDICAL CO., LTD.
Ophthalmic · 146d
Cleared Mar 19, 2026
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K254269
St. shine Optical Co., Ltd.
Ophthalmic · 79d
Cleared Mar 13, 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K252385
Pegavision Corporation
Ophthalmic · 225d
Cleared Feb 13, 2026
DAILIES TOTAL1®
K254052
Alcon Laboratories, Inc.
Ophthalmic · 58d
Cleared Dec 23, 2025
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)
K251683
Bruno Vision Care, LLC
Ophthalmic · 207d
Cleared Oct 07, 2025
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K250364
St. shine Optical Co., Ltd.
Ophthalmic · 239d
Cleared Sep 25, 2025
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear)
K244009
Yung Sheng Optical Co., Ltd.
Ophthalmic · 273d
Cleared Sep 17, 2025
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K251095
Pegavision Corporation
Ophthalmic · 160d
Cleared Sep 10, 2025
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
K251573
Vizionfocus, Inc.
Ophthalmic · 111d
Cleared Jul 30, 2025
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
K242855
E.O.S Co., Ltd.
Ophthalmic · 313d
Cleared Jul 02, 2025
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K243868
Pegavision Corporation
Ophthalmic · 197d
Cleared Apr 17, 2025
miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus
K242056
Benq Materials Corporation
Ophthalmic · 276d
Cleared Apr 10, 2025
Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
K243953
Vizionfocus, Inc.
Ophthalmic · 108d
Cleared Mar 20, 2025
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
K241884
Hunan Haipuming Technology Co., Ltd.
Ophthalmic · 265d
Cleared Feb 04, 2025
Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
K242916
Largan Medical Co., Ltd.
Ophthalmic · 133d
Cleared Jan 13, 2025
Precision1
K243909
Alcon Laboratories, Inc.
Ophthalmic · 25d
Cleared Dec 17, 2024
VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens
K242413
Vizionfocus, Inc.
Ophthalmic · 125d
Cleared Dec 16, 2024
Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
K232839
Yung Sheng Optical Co., Ltd.
Ophthalmic · 459d
Cleared Oct 25, 2024
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia
K240918
Bruno Vision Care, LLC
Ophthalmic · 205d
Cleared Oct 08, 2024
Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
K242391
Lucens Technology Co., Ltd.
Ophthalmic · 57d
Cleared Aug 14, 2024
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)
K242059
X-Cel Specialty Contacts, A Walman Optical Company
Ophthalmic · 30d

About Product Code LPL - Regulatory Context

510(k) Submission Activity

486 total 510(k) submissions under product code LPL since 1994, with 486 receiving FDA clearance (average review time: 116 days).

Submission volume has increased in recent years - 26 submissions in the last 24 months compared to 20 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LPL Product Code

Recent submissions under LPL have taken an average of 162 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.

LPL devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →