FDA Product Code LPN: Accessories, Soft Lens Products
Leading manufacturers include Bausch & Lomb, Inc., Ciba Vision Corporation and Alcon Laboratories.
121
Total
121
Cleared
130d
Avg days
1985
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
258d
recently vs 129d historically
FDA 510(k) Cleared Accessories, Soft Lens Products Devices (Product Code LPN)
121 devices
Cleared
Aug 13, 2026
MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
Menicon Co, Ltd.
Ophthalmic
258d
Cleared
Dec 06, 2022
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
Bausch & Lomb, Incorporated
Ophthalmic
106d
Cleared
Oct 12, 2022
Aqua Naina Plus Sterile Saline Solution
Chemtex USA, Inc.
Ophthalmic
163d
Cleared
May 28, 2021
ABT12 multi-purpose solution
Bausch & Lomb, Incorporated
Ophthalmic
241d
Cleared
May 26, 2021
OTE MPS 045 Multi-purpose Lens Care Solution
Ote North America, LLC
Ophthalmic
138d
Cleared
May 26, 2020
Aqua Naina Sterile Saline Solution
Chemtex USA, Inc.
Ophthalmic
167d
Cleared
May 15, 2020
PuriLens Plus Preservative Free Saline
The Lifestyle Company, Inc.
Ophthalmic
53d
Cleared
Mar 02, 2020
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
Menicon Co, Ltd.
Ophthalmic
234d
Cleared
Aug 08, 2019
REFRESH RELIEVA For CONTACTS
Allergan, Inc.
Ophthalmic
146d
Cleared
Jul 31, 2019
AOCup Lens Case with AODisc
Alcon Laboratories, Inc.
Ophthalmic
28d
Cleared
Apr 11, 2017
Bausch + Lomb Sensitive Eyes Plus Saline Solution
Bausch & Lomb, Incorporated
Ophthalmic
54d
Cleared
Nov 25, 2016
NNR06 Multi-Purpose Solution
Bausch & Lomb, Incorporated
Ophthalmic
147d
Cleared
Oct 19, 2016
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
Alcon Laboratories, Inc.
Ophthalmic
30d
Cleared
Aug 11, 2016
LensGiene Sterile Saline Solution
Optics Laboratory, Inc.
Ophthalmic
59d
Cleared
Aug 28, 2015
Menicon Saline Rinse Solution
Menicon Co, Ltd.
Ophthalmic
59d
Cleared
Jan 26, 2015
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE
Alcon Laboratories, Inc.
Ophthalmic
161d
Cleared
Sep 09, 2013
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
Bausch & Lomb, Incorporated
Ophthalmic
54d
Cleared
May 15, 2013
SAUFLON MULTIPURPOSE SOLUTION
Sauflon Pharmaceuticals, Ltd.
Ophthalmic
58d
Cleared
Apr 30, 2012
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
Bausch & Lomb, Inc.
Ophthalmic
210d
Cleared
Jan 24, 2012
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
Bausch & Lomb, Inc.
Ophthalmic
207d
Cleared
Nov 01, 2011
EYE-CEPT STERILE SALINE SOLUTION
Optics Laboratory, Inc.
Ophthalmic
280d
Cleared
May 10, 2011
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
Alcon Research, Ltd.
Ophthalmic
222d
Cleared
Jul 09, 2009
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
Allergan, Inc.
Ophthalmic
199d
Cleared
May 31, 2006
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
Lapis Lazuli, NV
Ophthalmic
394d
About Product Code LPN - Regulatory Context
510(k) Submission Activity
121 total 510(k) submissions under product code LPN since 1985, with 121 receiving FDA clearance (average review time: 130 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA 510(k) Review Time - LPN Product Code
Recent submissions under LPN have taken an average of 258 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.
LPN devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →