# K132216: Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Sep 9, 2013 after 54 days
- Product code: LPN (Accessories, Soft Lens Products)
- Device class: 2
- Regulation: 21 CFR 886.5928
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022687 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112909: OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Soultion, Bausch & Lomb, Inc. (2012) Summary page 2.

## Recalls of this device
- Sep 19, 2016 · Class II · Z-0651-2017: Product was found to contain excess residual levels of hydrogen peroxide.

## Indications for use
Bausch + Lomb PeroxiClearTM 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses, as recommended by your eye care practitioner.

Source page: https://510kreport.com/device/K132216
Methodology: https://510kreport.com/methodology