# K983836: Rigid Gas Permeable Contact Lens Solution

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Div. Wilmington Partners, L.P.
- Decided: Feb 11, 1999 after 104 days
- Product code: MRC (Products, Contact Lens Care, Rigid Gas Permeable)
- Device class: 2
- Regulation: 21 CFR 886.5918
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P820070: Boston Lens (R) Conditioning Solution, Polymer Technology Corp.. FDA lists this PMA only through its supplements; the earliest we hold is P820070/S004 (Mar 29, 1984). Summary page 1.

## Recalls of this device
- Oct 30, 2009 · Not classified · Z-0553-2010: The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or r
- Jun 30, 2009 · Not classified · Z-1735-2009: The product failed to meet one of the shelf life specifications at the end of the expiry period.

## Indications for use
Boston® Enhanced Original Formula Conditioning Solution is indicated for use in wetting, disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.

Source page: https://510kreport.com/device/K983836
Methodology: https://510kreport.com/methodology