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510(k) K252175

LANDR Contact LENS Case by Fourth Axis, LLC — Product Code LRX

K252175 is an FDA 510(k) premarket notification submitted by Fourth Axis, LLC for the device "LANDR Contact LENS Case". The FDA issued a decision of Substantially Equivalent on February 10, 2026. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2026
Date Received
July 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

Other clearances for product code LRX

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  • K240095 — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (October 9, 2024)
  • K231123 — Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Cas (August 30, 2023)
  • K173538 — Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (December 4, 2017)
  • K172925 — Contact Lens Case, Model: A-1, B-1 (November 30, 2017)
  • K173365 — Bausch + Lomb Boston Scleral Lens Case (November 17, 2017)
  • K171539 — Contact Lens Case (July 14, 2017)
  • K171163 — Contact Lens Case Round Glasses (June 27, 2017)
  • K162869 — Contact Lens Case (December 9, 2016)
  • K160005 — Contact Lens Case (multiple brand name) (June 7, 2016)

FDA data resources