FDA Product Code LPN: Accessories, Soft Lens Products
Leading manufacturers include Chemtex USA, Inc., Bausch & Lomb, Incorporated and Allergan, Inc..
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
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
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.