LPN — Accessories, Soft Lens Products Class II
FDA product code LPN covers "Accessories, Soft Lens Products", a Class II medical device regulated under 21 CFR 886.5928. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LPN
- Device Class
- Class II
- Regulation Number
- 886.5928
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K222541 | bausch and lomb, incorporated | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | December 6, 2022 |
| K221263 | chemtex usa | Aqua Naina Plus Sterile Saline Solution | October 12, 2022 |
| K202932 | bausch and lomb, incorporated | ABT12 multi-purpose solution | May 28, 2021 |
| K210051 | ote north america | OTE MPS 045 Multi-purpose Lens Care Solution | May 26, 2021 |
| K193441 | chemtex usa | Aqua Naina Sterile Saline Solution | May 26, 2020 |
| K200747 | lifestyle company | PuriLens Plus Preservative Free Saline | May 15, 2020 |
| K191872 | menicon co | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | March 2, 2020 |
| K190674 | allergan | REFRESH RELIEVA For CONTACTS | August 8, 2019 |
| K191795 | alcon laboratories | AOCup Lens Case with AODisc | July 31, 2019 |
| K170483 | bausch and lomb, incorporated | Bausch + Lomb Sensitive Eyes Plus Saline Solution | April 11, 2017 |
| K161819 | bausch and lomb, incorporated | NNR06 Multi-Purpose Solution | November 25, 2016 |
| K162597 | alcon laboratories | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | October 19, 2016 |
| K161622 | optics laboratory | LensGiene Sterile Saline Solution | August 11, 2016 |
| K151768 | menicon co | Menicon Saline Rinse Solution | August 28, 2015 |
| K142284 | alcon laboratories | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE | January 26, 2015 |
| K132216 | bausch and lomb, incorporated | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION | September 9, 2013 |
| K130734 | sauflon pharmaceuticals | SAUFLON MULTIPURPOSE SOLUTION | May 15, 2013 |
| K112909 | bausch and lomb | OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION | April 30, 2012 |
| K111877 | bausch and lomb | EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISIN | January 24, 2012 |
| K110221 | optics laboratory | EYE-CEPT STERILE SALINE SOLUTION | November 1, 2011 |