Cleared Traditional

K252175 - LANDR Contact LENS Case (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K252175 is an FDA 510(k) clearance for the LANDR Contact LENS Case. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Fourth Axis, LLC (Boise, US). The FDA issued a Cleared decision on February 10, 2026 after a review of 214 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Fourth Axis, LLC devices

Submission Details

510(k) Number K252175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 110d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRX Case, Contact Lens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Bdra Consulting, LLC
Srinagesh Koushik

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LRX Case, Contact Lens

All 81
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K252175.
MINI VP1 (PL67_F)
K250495 · Avizor S.A. · Aug 2025
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
K240095 · Shanghai Care US Medical Product Co., Ltd. · Oct 2024
Phoenix Contact Lens Case - dome top flat pack (CL-01)
K231123 · Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. · Aug 2023