LPN · Accessories, Soft Lens Products
Ophthalmic · 21 CFR 886.5928 · Class 2
Overview
| Product Code | LPN |
|---|---|
| Device Name | Accessories, Soft Lens Products |
| Regulation | 21 CFR 886.5928 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
Classification Rationale
Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
Special Controls
*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
Recent Cleared Devices (20 of 122)
Showing 20 most recent of 122 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | Bausch & Lomb, Incorporated | Dec 6, 2022 | SESE |
| K221263 | Aqua Naina Plus Sterile Saline Solution | Chemtex USA, Inc. | Oct 12, 2022 | SESE |
| K202932 | ABT12 multi-purpose solution | Bausch & Lomb, Incorporated | May 28, 2021 | SESE |
| K210051 | OTE MPS 045 Multi-purpose Lens Care Solution | Ote North America, LLC | May 26, 2021 | SESE |
| K193441 | Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. | May 26, 2020 | SESE |
| K200747 | PuriLens Plus Preservative Free Saline | The Lifestyle Company, Inc. | May 15, 2020 | SESE |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Menicon Co, Ltd. | Mar 2, 2020 | SESE |
| K190674 | REFRESH RELIEVA For CONTACTS | Allergan, Inc. | Aug 8, 2019 | SESE |
| K191795 | AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | Jul 31, 2019 | SESE |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | Apr 11, 2017 | SESE |
| K161819 | NNR06 Multi-Purpose Solution | Bausch & Lomb, Incorporated | Nov 25, 2016 | SESE |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | Oct 19, 2016 | SESE |
| K161622 | LensGiene Sterile Saline Solution | Optics Laboratory, Inc. | Aug 11, 2016 | SESE |
| K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | Aug 28, 2015 | SESE |
| K142284 | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE | Alcon Laboratories, Inc. | Jan 26, 2015 | SESE |
| K132216 | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION | Bausch & Lomb, Incorporated | Sep 9, 2013 | SESE |
| K130734 | SAUFLON MULTIPURPOSE SOLUTION | Sauflon Pharmaceuticals, Ltd. | May 15, 2013 | SESE |
| K112909 | OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION | Bausch & Lomb, Inc. | Apr 30, 2012 | SESE |
| K111877 | EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION | Bausch & Lomb, Inc. | Jan 24, 2012 | SESE |
| K110221 | EYE-CEPT STERILE SALINE SOLUTION | Optics Laboratory, Inc. | Nov 1, 2011 | SESE |
Top Applicants
- Bausch & Lomb, Inc. — 15 clearances
- Alcon Laboratories — 14 clearances
- Ciba Vision Corporation — 14 clearances
- Allergan, Inc. — 12 clearances
- Bausch & Lomb, Incorporated — 5 clearances
