# K052074: JSZ-Stat-Tree, and JSZ-Stat-or, Cleaning, Disinfecting and Storing Solutions; JSZ-Wet-Tree and JSZ-Wet-or, Wetting,

- Pathway: 510(k) (Traditional)
- Applicant: Szabocsik and Associates
- Decided: Sep 1, 2005 after 31 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
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)
- None. The FDA summary names its predicate without a number.
- (no number) DeStat-3 Cleaning, Disinfecting and Storage Solution: named in the summary without a submission number
- (no number) DeStat-4 Cleaning, Disinfecting and Storage Solution: named in the summary without a submission number
- (no number) Stay-Wet 3 Wetting and Rewetting Drops: named in the summary without a submission number
- (no number) Stay-Wet 4 Wetting and Rewetting Drops: named in the summary without a submission number
- (no number) Optimum by Lobob Cleaning, Disinfecting and Storage Solution: named in the summary without a submission number
- (no number) Optimum by Lobob Wetting and Rewetting Drops: named in the summary without a submission number
- (no number) Claris by Menicon Cleaning and Soaking Solution: named in the summary without a submission number

## Indications for use
JSZ-Stat-Tree Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses. JSZ-Stat-Or Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses. JSZ-Wet-Tree Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye. JSZ-Wet-Or Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye.

Source page: https://510kreport.com/device/K052074
Methodology: https://510kreport.com/methodology