Cleared Traditional

LANDR Contact LENS Case

K252175 · Fourth Axis, LLC · Ophthalmic
Feb 2026
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K252175 is an FDA 510(k) clearance for the LANDR Contact LENS Case, a Case, Contact Lens (Class II — Special Controls, product code LRX), submitted by Fourth Axis, LLC (Boise, US). The FDA issued a Cleared decision on February 10, 2026, 214 days after receiving the submission on July 11, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K252175 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2025
Decision Date February 10, 2026
Days to Decision 214 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LRX — Case, Contact Lens
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

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