# K180319: Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution

- Pathway: 510(k) (Traditional)
- Applicant: Bausch and Lomb, Incorporated
- Decided: Mar 27, 2018 after 50 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: 5 generations back to K002319 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974466: Boston Advance Cleaner, Polymer Technology Corp. (1998) Summary page 4.
- K170483: Bausch + Lomb Sensitive Eyes Plus Saline Solution, Bausch & Lomb, Incorporated (2017) Summary page 4.

## Cited in the summary but kept off the family tree
- P920055: Bausch + Lomb Boston ADVANCE Conditioning Solution. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4.

## Indications for use
Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting). Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.

Source page: https://510kreport.com/device/K180319
Methodology: https://510kreport.com/methodology