Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5925](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5925) → LPL — Lenses, Soft Contact, Daily Wear # LPL · Lenses, Soft Contact, Daily Wear _Ophthalmic · 21 CFR 886.5925 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL ## Overview - **Product Code:** LPL - **Device Name:** Lenses, Soft Contact, Daily Wear - **Regulation:** [21 CFR 886.5925](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5925) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K254269.md) | 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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K252385.md) | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | Mar 13, 2026 | SESE | | [K254052](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K254052.md) | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories, Inc. | Feb 13, 2026 | SESE | | [K251683](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K251683.md) | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) | Bruno Vision Care, LLC | Dec 23, 2025 | SESE | | [K250364](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K250364.md) | 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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K244009.md) | 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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K251095.md) | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | Sep 17, 2025 | SESE | | [K251573](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K251573.md) | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus, Inc. | Sep 10, 2025 | SESE | | [K242855](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K242855.md) | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | E.O.S Co., Ltd. | Jul 30, 2025 | SESE | | [K243868](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K243868.md) | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | Jul 2, 2025 | SESE | | [K242056](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K242056.md) | 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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K243953.md) | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Vizionfocus, Inc. | Apr 10, 2025 | SESE | | [K241884](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K241884.md) | HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) | Hunan Haipuming Technology Co., Ltd. | Mar 20, 2025 | SESE | | [K242916](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K242916.md) | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | Feb 4, 2025 | SESE | | [K243909](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K243909.md) | 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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K242413.md) | 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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K232839.md) | 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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K240918.md) | 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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K242391.md) | Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Lucens Technology Co., Ltd. | Oct 8, 2024 | SESE | | [K242059](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K242059.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com