LPN · Class II · 21 CFR 886.5928

FDA Product Code LPN: Accessories, Soft Lens Products

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

120
Total
120
Cleared
129d
Avg days
1985
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Accessories, Soft Lens Products Devices (Product Code LPN)

120 devices
1–24 of 120
Cleared Dec 06, 2022
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
K222541
Bausch & Lomb, Incorporated
Ophthalmic · 106d
Cleared Oct 12, 2022
Aqua Naina Plus Sterile Saline Solution
K221263
Chemtex USA, Inc.
Ophthalmic · 163d
Cleared May 28, 2021
ABT12 multi-purpose solution
K202932
Bausch & Lomb, Incorporated
Ophthalmic · 241d
Cleared May 26, 2021
OTE MPS 045 Multi-purpose Lens Care Solution
K210051
Ote North America, LLC
Ophthalmic · 138d
Cleared May 26, 2020
Aqua Naina Sterile Saline Solution
K193441
Chemtex USA, Inc.
Ophthalmic · 167d
Cleared May 15, 2020
PuriLens Plus Preservative Free Saline
K200747
The Lifestyle Company, Inc.
Ophthalmic · 53d
Cleared Mar 02, 2020
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
K191872
Menicon Co, Ltd.
Ophthalmic · 234d
Cleared Aug 08, 2019
REFRESH RELIEVA For CONTACTS
K190674
Allergan, Inc.
Ophthalmic · 146d
Cleared Jul 31, 2019
AOCup Lens Case with AODisc
K191795
Alcon Laboratories, Inc.
Ophthalmic · 28d
Cleared Oct 19, 2016
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K162597
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Jan 26, 2015
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE
K142284
Alcon Laboratories, Inc.
Ophthalmic · 161d
Cleared Apr 30, 2012
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
K112909
Bausch & Lomb, Inc.
Ophthalmic · 210d
Cleared Jan 24, 2012
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
K111877
Bausch & Lomb, Inc.
Ophthalmic · 207d
Cleared Aug 10, 2005
AQUIFY MULTIPURPOSE SOLUTION
K050250
Ciba Vision Corporation
Ophthalmic · 188d
Cleared Nov 03, 2004
AQUIFY LENS COMFORT DROPS
K042176
Ciba Vision Corporation
Ophthalmic · 84d
Cleared Oct 28, 2004
KARATS MULTIPURPOSE SOLUTION
K031753
Ciba Vision Corporation
Ophthalmic · 511d
Cleared Feb 02, 2004
AQUIFY MULTI-PURPOSE SOLUTION
K033608
Ciba Vision Corporation
Ophthalmic · 77d
Cleared Nov 14, 2003
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
K031646
Bausch & Lomb, Inc.
Ophthalmic · 170d
Cleared Sep 12, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K030522
Ciba Vision Corporation
Ophthalmic · 205d
Cleared Aug 14, 2003
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
K031957
Ciba Vision Corporation
Ophthalmic · 50d
Cleared Jun 27, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K031521
Ciba Vision Corporation
Ophthalmic · 43d
Cleared Jun 27, 2003
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K031522
Ciba Vision Corporation
Ophthalmic · 43d
Cleared Oct 28, 2002
KARATS MULTIPURPOSE SOLUTION
K021635
Ciba Vision Corporation
Ophthalmic · 164d
Cleared Dec 26, 2001
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K012731
Ciba Vision Corporation
Ophthalmic · 133d

About Product Code LPN - Regulatory Context

510(k) Submission Activity

120 total 510(k) submissions under product code LPN since 1985, with 120 receiving FDA clearance (average review time: 129 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.