# K181627: Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Aug 10, 2018 after 51 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: 2 generations back to P850093/S003 (1989). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024289: Boston BL-1000-SIM08 Multi-Action Solution, Bausch & Lomb, Incorporated (2003) Summary page 4.
- K973217: Boston Liquid Enzymatic Cleaner, Polymer Technology Corp. (1997) Summary page 4.

## Most influential descendants
- K251876: cleadew GP hydra one (2025), 0 descendants of its own
- K200416: Boston One Step Liquid Enzymatic Cleaner (2020), 0 descendants of its own

## Indications for use
Bausch + Lomb Boston Simplus Multi-Action Solution is indicated for cleaning, removing protein, rinsing, disinfecting, conditioning, storing and cushioning fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses. Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone 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/K181627
Methodology: https://510kreport.com/methodology