| K-number | K252175 |
| Device name | LANDR Contact LENS Case |
| Applicant | Fourth Axis, LLC |
| Product code | LRX |
| Device class | Class II |
| Decision date | Feb 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 886.5928 |
The LANDR Contact Lens Case is a dual-compartment storage device designed to hold soft (hydrophilic), rigid gas-permeable, and rigid contact lenses. Each compartment has a screw-down lid and can be separated for individual use. The device is intended for storage with chemical disinfection solutions only and must not be used during heat disinfection.
The LANDR case is manufactured from polypropylene with two color-coded wells (one color per well) that can be connected via a ball plunger for shipping and carrying. It has a maximum fill volume of 3.85 ml and is sold in a single color combination. The design allows the cases to be separated and placed upright on a flat surface for proper lens storage orientation.
ISO 10993-1 (Biological evaluation framework), ISO 10993-5 (Cytotoxicity testing), ISO 10993-10 (Irritation and sensitization), ISO 10993-11 (Systemic toxicity), and ISO 10993-23 (Ocular irritation testing). Performance testing included simulated leak tests for 8 hours of storage, including evaluation when cases were stored upside down.
The LANDR case is substantially equivalent to the CAREUS Contact Lens Case predicate because both devices have identical intended use (storage with chemical disinfection only), are manufactured from the same material (polypropylene), share similar dual-well design with screw-down lids, and are intended for upright storage on a flat surface. Minor differences in color options, volume range, and size variations do not affect safety or performance, and both devices meet the same biocompatibility and leak-testing requirements.
View the full FDA submission: accessdata.fda.gov