LRX · Class II · 21 CFR 886.5928

FDA Product Code LRX: Case, Contact Lens

Leading manufacturers include Alcon Laboratories, Paragon Vision Sciences and Bausch & Lomb, Inc..

82
Total
82
Cleared
115d
Avg days
1984
Since
Growing category - 3 submissions in the last 2 years vs 2 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 30, 2017
Contact Lens Case, Model: A-1, B-1
K172925
P L Overseas Limited
Ophthalmic · 66d
Cleared Nov 17, 2017
Bausch + Lomb Boston Scleral Lens Case
K173365
Bausch & Lomb, Incorporated
Ophthalmic · 22d
Cleared Jul 14, 2017
Contact Lens Case
K171539
E-Link Plastic & Metal Industrial Co.,Ltd
Ophthalmic · 49d
Cleared Jun 27, 2017
Contact Lens Case Round Glasses
K171163
Fiftytwoways, Ltd.
Ophthalmic · 68d
Cleared Dec 09, 2016
Contact Lens Case
K162869
Ningbo Yinzhou Zonghai Artware Co., Ltd.
Ophthalmic · 57d
Cleared Jun 07, 2016
Contact Lens Case (multiple brand name)
K160005
Danyang Chanxin Glasses Cases Factory
Ophthalmic · 155d
Cleared May 07, 2015
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
K142717
Ni Hau Industrial Co., Ltd.
Ophthalmic · 226d
Cleared Apr 29, 2015
iCase Contact Lens Case
K143351
Novabay Pharmaceuticals, Inc.
Ophthalmic · 156d
Cleared Sep 10, 2014
CONTACT LENS CASE
K140488
Maca Plastics, Inc.
Ophthalmic · 195d
Cleared Feb 21, 2014
POLAROID CONTACTSPOD
K131783
Viopti, Ltd.
Ophthalmic · 249d
Cleared Feb 12, 2014
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
K130930
Ningbo Lishunda Electronics Co., Ltd.
Ophthalmic · 314d
Cleared Aug 06, 2013
MENICON NECT CONTACT LENS CASE
K131875
Foresight Regulatory Strategies
Ophthalmic · 43d
Cleared Jun 13, 2013
STANDARD CONTACT LENS CASE
K130753
Watchdog Group, LC
Ophthalmic · 86d
Cleared May 31, 2013
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
K122700
Prosben, Inc.
Ophthalmic · 269d
Cleared Apr 03, 2013
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
K130285
The Lagado Corp.
Ophthalmic · 57d
Cleared Nov 26, 2012
POLARIS DIAL-A-DATE CONTACT LENS CASE
K120904
Reliance Design & Manufacture Corp.
Ophthalmic · 245d
Cleared Jul 11, 2012
AC LENS BRANDED CONTACT LENS CASE
K120969
Arlington Contact Lens Services,Inc.
Ophthalmic · 103d
Cleared Jul 06, 2012
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
K121030
Sacks Holdings, Inc.
Ophthalmic · 92d
Cleared Dec 05, 2011
EYE CARE CURE CONTACT LENS CASE
K112832
Eye Care and Cure
Ophthalmic · 67d

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 2 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 →