LRX · Class II · 21 CFR 886.5928

FDA Product Code LRX: Case, Contact Lens

Leading manufacturers include Alcon Laboratories, Bausch & Lomb, Inc. and Ciba Vision Corporation.

82
Total
82
Cleared
115d
Avg days
1984
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 216d recently vs 111d historically

FDA 510(k) Cleared Case, Contact Lens Devices (Product Code LRX)

82 devices
1–24 of 82
Cleared Feb 10, 2026
LANDR Contact LENS Case
K252175
Fourth Axis, LLC
Ophthalmic · 214d
Cleared Aug 01, 2025
MINI VP1 (PL67_F)
K250495
Avizor S.A.
Ophthalmic · 162d
Cleared Oct 09, 2024
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
K240095
Shanghai Care US Medical Product Co., Ltd.
Ophthalmic · 271d
Cleared Aug 30, 2023
Phoenix Contact Lens Case - dome top flat pack (CL-01)
K231123
Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
Ophthalmic · 132d
Cleared Dec 04, 2017
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K173538
Alcon Laboratories, Inc.
Ophthalmic · 19d
Cleared Nov 17, 2017
Bausch + Lomb Boston Scleral Lens Case
K173365
Bausch & Lomb, Incorporated
Ophthalmic · 22d
Cleared Sep 09, 2005
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820
Ciba Vision Corporation
Ophthalmic · 430d
Cleared Nov 20, 2001
CYBERCASES BY BAUSCH & LOMB
K013232
Bausch & Lomb, Inc.
Ophthalmic · 54d
Cleared Jan 20, 1998
ALCON CONTACT LENS CASE
K974281
Alcon Laboratories
Ophthalmic · 67d
Cleared Jul 14, 1997
ALCON CONTACT LENS CASE
K971618
Alcon Laboratories
Ophthalmic · 73d
Cleared Jun 26, 1995
BOSTON CONTACT LENS CASE
K951552
Polymer Technology Corp.
Ophthalmic · 83d
Cleared Aug 04, 1994
CIBA VISION(R) CONTACT LENS CASE
K943183
Ciba Vision Corporation
Ophthalmic · 34d
Cleared Jun 28, 1993
OPTI-FREE CONTACT LENS CASE
K931620
Alcon Laboratories
Ophthalmic · 87d
Cleared Dec 26, 1989
BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM
K896685
Bausch & Lomb, Inc.
Ophthalmic · 28d

About Product Code LRX - Regulatory Context

510(k) Submission Activity

82 total 510(k) submissions under product code LRX since 1984, with 82 receiving FDA clearance (average review time: 115 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LRX Product Code

Recent submissions under LRX have taken an average of 216 days to reach a decision - up from 111 days historically. Manufacturers should account for longer review timelines in current project planning.

LRX devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →