K-numberK252175
Device nameLANDR Contact LENS Case
ApplicantFourth Axis, LLC
Product codeLRX
Device classClass II
Decision dateFeb 10, 2026
DecisionSubstantially Equivalent
Regulation886.5928
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

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.

Technological characteristics

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.

Test standards cited

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.

Substantial equivalence argument

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.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?
Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.
Start free trial →

Everything you need for a 510(k) submission. Nothing you don't.

14-day free trial. No setup. Cancel anytime.

Start free trial →
Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →