# K253795: MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

- Pathway: 510(k) (Traditional)
- Applicant: Menicon Co, Ltd.
- Decided: Aug 13, 2026 after 258 days
- Product code: LPN (Accessories, Soft Lens Products)
- Device class: 2
- Regulation: 21 CFR 886.5928
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003345 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191872: Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution, Menicon Co, Ltd. (2020) Summary page 6.

## Indications for use
MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.

Source page: https://510kreport.com/device/K253795
Methodology: https://510kreport.com/methodology