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) → LRX — Case, Contact Lens # LRX · Case, Contact Lens _Ophthalmic · 21 CFR 886.5928 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX ## Overview - **Product Code:** LRX - **Device Name:** Case, Contact Lens - **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 82) Showing 20 most recent of 82 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252175](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K252175.md) | LANDR Contact LENS Case | Fourth Axis, LLC | Feb 10, 2026 | SESE | | [K250495](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K250495.md) | MINI VP1 (PL67_F); MINI VP1 (PL61_F) | Avizor S.A. | Aug 1, 2025 | SESE | | [K240095](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K240095.md) | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) | Shanghai Care US Medical Product Co., Ltd. | Oct 9, 2024 | SESE | | [K231123](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K231123.md) | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) | Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. | Aug 30, 2023 | SESE | | [K173538](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K173538.md) | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | Dec 4, 2017 | SESE | | [K172925](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K172925.md) | Contact Lens Case, Model: A-1, B-1 | P L Overseas Limited | Nov 30, 2017 | SESE | | [K173365](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K173365.md) | Bausch + Lomb Boston Scleral Lens Case | Bausch & Lomb, Incorporated | Nov 17, 2017 | SESE | | [K171539](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K171539.md) | Contact Lens Case | E-Link Plastic & Metal Industrial Co.,Ltd | Jul 14, 2017 | SESE | | [K171163](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K171163.md) | Contact Lens Case Round Glasses | Fiftytwoways, Ltd. | Jun 27, 2017 | SESE | | [K162869](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K162869.md) | Contact Lens Case | Ningbo Yinzhou Zonghai Artware Co., Ltd. | Dec 9, 2016 | SESE | | [K160005](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K160005.md) | Contact Lens Case (multiple brand name) | Danyang Chanxin Glasses Cases Factory | Jun 7, 2016 | SESE | | [K142717](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K142717.md) | Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case | Ni Hau Industrial Co., Ltd. | May 7, 2015 | SESE | | [K143351](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K143351.md) | iCase Contact Lens Case | Novabay Pharmaceuticals, Inc. | Apr 29, 2015 | SESE | | [K140488](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K140488.md) | CONTACT LENS CASE | Maca Plastics, Inc. | Sep 10, 2014 | SESE | | [K131783](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K131783.md) | POLAROID CONTACTSPOD | Viopti, Ltd. | Feb 21, 2014 | SESE | | [K130930](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K130930.md) | OWL CONTACT LENS CASES, DOG CONTACT LENS CASES | Ningbo Lishunda Electronics Co., Ltd. | Feb 12, 2014 | SESE | | [K131875](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K131875.md) | MENICON NECT CONTACT LENS CASE | Foresight Regulatory Strategies | Aug 6, 2013 | SESE | | [K130753](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K130753.md) | STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE | Watchdog Group, LC | Jun 13, 2013 | SESE | | [K122700](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K122700.md) | PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES | Prosben, Inc. | May 31, 2013 | SESE | | [K130285](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K130285.md) | PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS | The Lagado Corp. | Apr 3, 2013 | SESE | ## Top Applicants - Applied Laboratories, Inc. — 6 clearances - Magnivision, Inc. — 6 clearances - Alcon Laboratories — 3 clearances - Kestrel — 3 clearances - Paragon Vision Sciences — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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