# K200416: Boston One Step Liquid Enzymatic Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Sep 23, 2020 after 216 days
- Product code: MRC (Products, Contact Lens Care, Rigid Gas Permeable)
- Device class: 2
- Regulation: 21 CFR 886.5918
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P850093/S003 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181627: Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner, Bausch & Lomb, Incorporated (2018) Summary page 4.

## Indications for use
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses during conditioning (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.

Source page: https://510kreport.com/device/K200416
Methodology: https://510kreport.com/methodology