LRX · Case, Contact Lens
Ophthalmic · 21 CFR 886.5928 · Class 2
Overview
| Product Code | LRX |
|---|---|
| Device Name | Case, Contact Lens |
| Regulation | 21 CFR 886.5928 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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 | LANDR Contact LENS Case | Fourth Axis, LLC | Feb 10, 2026 | SESE |
| K250495 | MINI VP1 (PL67_F); MINI VP1 (PL61_F) | Avizor S.A. | Aug 1, 2025 | SESE |
| K240095 | 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 | 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 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | Dec 4, 2017 | SESE |
| K172925 | Contact Lens Case, Model: A-1, B-1 | P L Overseas Limited | Nov 30, 2017 | SESE |
| K173365 | Bausch + Lomb Boston Scleral Lens Case | Bausch & Lomb, Incorporated | Nov 17, 2017 | SESE |
| K171539 | Contact Lens Case | E-Link Plastic & Metal Industrial Co.,Ltd | Jul 14, 2017 | SESE |
| K171163 | Contact Lens Case Round Glasses | Fiftytwoways, Ltd. | Jun 27, 2017 | SESE |
| K162869 | Contact Lens Case | Ningbo Yinzhou Zonghai Artware Co., Ltd. | Dec 9, 2016 | SESE |
| K160005 | Contact Lens Case (multiple brand name) | Danyang Chanxin Glasses Cases Factory | Jun 7, 2016 | SESE |
| K142717 | 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 | iCase Contact Lens Case | Novabay Pharmaceuticals, Inc. | Apr 29, 2015 | SESE |
| K140488 | CONTACT LENS CASE | Maca Plastics, Inc. | Sep 10, 2014 | SESE |
| K131783 | POLAROID CONTACTSPOD | Viopti, Ltd. | Feb 21, 2014 | SESE |
| K130930 | OWL CONTACT LENS CASES, DOG CONTACT LENS CASES | Ningbo Lishunda Electronics Co., Ltd. | Feb 12, 2014 | SESE |
| K131875 | MENICON NECT CONTACT LENS CASE | Foresight Regulatory Strategies | Aug 6, 2013 | SESE |
| K130753 | STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE | Watchdog Group, LC | Jun 13, 2013 | SESE |
| K122700 | PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES | Prosben, Inc. | May 31, 2013 | SESE |
| K130285 | 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
