# K973217: Boston Liquid Enzymatic Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Corp.
- Decided: Nov 24, 1997 after 89 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: 1 generation back to P850093/S003 (1989). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P820001/S021: Opti-Zyme Enzymatic Cleaner, Alcon Laboratories (1997). A supplement to the PMA, as the summary prints it.
- P850093/S003: B&L Therma-Zyme, Fizziclean, Bausch & Lomb, Inc. (1989). A supplement to the PMA, as the summary prints it.

## Most influential descendants
- K181627: Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner (2018), 2 descendants of its own
- 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
The Boston® Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during simultaneous conditioning (wetting, soaking, and disinfecting) with Original Formula Boston® Conditioning Solution, Boston ADVANCE® Comfort Formula Conditioning Solution, or Boston SIMPLICITY® Multi-Action Solution.

Source page: https://510kreport.com/device/K973217
Methodology: https://510kreport.com/methodology