LPL · Lenses, Soft Contact, Daily Wear
Ophthalmic · 21 CFR 886.5925 · Class 2
Overview
| Product Code | LPL |
|---|---|
| Device Name | Lenses, Soft Contact, Daily Wear |
| Regulation | 21 CFR 886.5925 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.
Classification Rationale
(1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
Recent Cleared Devices (20 of 490)
Showing 20 most recent of 490 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. shine Optical Co., Ltd. | Mar 19, 2026 | SESE |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | Mar 13, 2026 | SESE |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories, Inc. | Feb 13, 2026 | SESE |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) | Bruno Vision Care, LLC | Dec 23, 2025 | SESE |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. shine Optical Co., Ltd. | Oct 7, 2025 | SESE |
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) | Yung Sheng Optical Co., Ltd. | Sep 25, 2025 | SESE |
| K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | Sep 17, 2025 | SESE |
| K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus, Inc. | Sep 10, 2025 | SESE |
| K242855 | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | E.O.S Co., Ltd. | Jul 30, 2025 | SESE |
| K243868 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | Jul 2, 2025 | SESE |
| K242056 | miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus | Benq Materials Corporation | Apr 17, 2025 | SESE |
| K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Vizionfocus, Inc. | Apr 10, 2025 | SESE |
| K241884 | HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) | Hunan Haipuming Technology Co., Ltd. | Mar 20, 2025 | SESE |
| K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | Feb 4, 2025 | SESE |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric | Alcon Laboratories, Inc. | Jan 13, 2025 | SESE |
| K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens | Vizionfocus, Inc. | Dec 17, 2024 | SESE |
| K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear | Yung Sheng Optical Co., Ltd. | Dec 16, 2024 | SESE |
| K240918 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism | Bruno Vision Care, LLC | Oct 25, 2024 | SESE |
| K242391 | Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Lucens Technology Co., Ltd. | Oct 8, 2024 | SESE |
| K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) | X-Cel Specialty Contacts, A Walman Optical Company | Aug 14, 2024 | SESE |
Top Applicants
- CooperVision, Inc. — 37 clearances
- Alcon Laboratories, Inc. — 22 clearances
- Ciba Vision Corporation — 21 clearances
- Unilens Corp., USA — 14 clearances
- Pegavision Corporation — 12 clearances
