Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5928](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5928) → LPN — Accessories, Soft Lens Products # LPN · Accessories, Soft Lens Products _Ophthalmic · 21 CFR 886.5928 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN ## Overview - **Product Code:** LPN - **Device Name:** Accessories, Soft Lens Products - **Regulation:** [21 CFR 886.5928](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5928) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## Identification A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat. ## Classification Rationale Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.” ## Special Controls *Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.” ## Recent Cleared Devices (20 of 122) Showing 20 most recent of 122 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K222541](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K222541.md) | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | Bausch & Lomb, Incorporated | Dec 6, 2022 | SESE | | [K221263](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K221263.md) | Aqua Naina Plus Sterile Saline Solution | Chemtex USA, Inc. | Oct 12, 2022 | SESE | | [K202932](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K202932.md) | ABT12 multi-purpose solution | Bausch & Lomb, Incorporated | May 28, 2021 | SESE | | [K210051](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K210051.md) | OTE MPS 045 Multi-purpose Lens Care Solution | Ote North America, LLC | May 26, 2021 | SESE | | [K193441](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K193441.md) | Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. | May 26, 2020 | SESE | | [K200747](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K200747.md) | PuriLens Plus Preservative Free Saline | The Lifestyle Company, Inc. | May 15, 2020 | SESE | | [K191872](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K191872.md) | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Menicon Co, Ltd. | Mar 2, 2020 | SESE | | [K190674](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K190674.md) | REFRESH RELIEVA For CONTACTS | Allergan, Inc. | Aug 8, 2019 | SESE | | [K191795](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K191795.md) | AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | Jul 31, 2019 | SESE | | [K170483](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K170483.md) | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | Apr 11, 2017 | SESE | | [K161819](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K161819.md) | NNR06 Multi-Purpose Solution | Bausch & Lomb, Incorporated | Nov 25, 2016 | SESE | | [K162597](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K162597.md) | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | Oct 19, 2016 | SESE | | [K161622](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K161622.md) | LensGiene Sterile Saline Solution | Optics Laboratory, Inc. | Aug 11, 2016 | SESE | | [K151768](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K151768.md) | Menicon Saline Rinse Solution | Menicon Co, Ltd. | Aug 28, 2015 | SESE | | [K142284](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K142284.md) | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE | Alcon Laboratories, Inc. | Jan 26, 2015 | SESE | | [K132216](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K132216.md) | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION | Bausch & Lomb, Incorporated | Sep 9, 2013 | SESE | | [K130734](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K130734.md) | SAUFLON MULTIPURPOSE SOLUTION | Sauflon Pharmaceuticals, Ltd. | May 15, 2013 | SESE | | [K112909](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K112909.md) | OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION | Bausch & Lomb, Inc. | Apr 30, 2012 | SESE | | [K111877](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K111877.md) | EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION | Bausch & Lomb, Inc. | Jan 24, 2012 | SESE | | [K110221](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN/K110221.md) | EYE-CEPT STERILE SALINE SOLUTION | Optics Laboratory, Inc. | Nov 1, 2011 | SESE | ## Top Applicants - Bausch & Lomb, Inc. — 15 clearances - Alcon Laboratories — 14 clearances - Ciba Vision Corporation — 14 clearances - Allergan, Inc. — 12 clearances - Bausch & Lomb, Incorporated — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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