# K242732: Tristel OPH

- Pathway: 510(k) (Traditional)
- Applicant: Tristel Solutions, Ltd.
- Decided: May 9, 2025 after 241 days
- Product code: QWS (Foam Or Gel Chemical Sterilant/High Level Disinfectant)
- Device class: 2
- Regulation: 21 CFR 880.6886
- 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 DEN220041 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220041: Tristel Duo ULT, Tristel Solutions Limited (2023) Summary page 5.

## Indications for use
Tristel OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be used to high level disinfect devices that may contact mucous membranes during use, such as diagnostic and laser lenses, tonometer prisms, pachymeters, retinal imaging probes, A-scan and B-scan probes. Tristel OPH is a high level disinfectant when used in accordance with the Directions for Use, including a disinfection contact time of 2 minutes, at room temperature and a concentration at or above Minimum Recommended Concentration (MRC). Tristel OPH Foam must be applied on the surface of an ophthalmic device using Tristel OPH Wipes. Tristel OPH Wipes are intended for application of Tristel OPH Foam on the surface of ophthalmic devices and to remove residue of the foam after high level disinfection. Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single use. The semi-critical ophthalmic devices processed by Tristel OPH must first be cleaned according to a validated cleaning protocol or standard and following the device manufacturers’ instructions. Tristel OPH Foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC. Minimum Recommended Concentration (MRC): ~90% v/v (~280ppm) at point of use. MRC of Tristel OPH may be verified using Tristel Test Strips.

Source page: https://510kreport.com/device/K242732
Methodology: https://510kreport.com/methodology