LANDR Contact LENS Case— 510(k) K252175
Substantially EquivalentFourth Axis, LLC
FDA 510(k) clearance K252175 for LANDR Contact LENS Case, Substantially Equivalent on 2026-02-10. Applicant: Fourth Axis, LLC. Device class: 2.
Summary
Fourth Axis's LANDR Contact LENS Case is filed under product code LRX, contact lens case. The record doesn't describe the case beyond its name and that code name.
Class II, 21 CFR 886.5928. Ophthalmic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Fourth Axis filed from Boise, Idaho. The decision came 214 calendar days after FDA received it (July 11, 2025 to February 10, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Fourth Axis, LLC
- Product code
- Product code LRX
- Device class
- Class 2
- Regulation
- 21 CFR 886.5928
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boise, ID, US
Recent devices under product code LRX
view all- K250495 — MINI VP1 (PL67_F); MINI VP1 (PL61_F)
- K240095 — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
- K231123 — Phoenix Contact Lens Case - dome top flat pack (CL-01) +2 more
- K173538 — Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
- K172925 — Contact Lens Case, Model: A-1, B-1
Data sourced from openFDA. This site is unofficial and independent of the FDA.