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510(k) Data Aggregation
K Number
K242732Device Name
Tristel OPH
Manufacturer
Date Cleared
2025-05-09
(241 days)
Product Code
Regulation Number
880.6886Why did this record match?
Applicant Name (Manufacturer) :
Tristel Solutions Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
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, and A-scan and B-scan probes.
Tristel OPH Foam is packaged in a hand-held dispenser bottle. Tristel OPH Foam is made of two solutions, Tristel OPH Activator solution and Tristel OPH Base solution, which are mixed when dispensed to generate active ingredient chlorine dioxide. In-use concentration of chlorine dioxide (ClO2) is 0.032% (320ppm).
Tristel OPH Foam Activator and Base solutions are contained in a dual compartment bottle with a dispenser pump and are ready to use.
Tristel OPH Foam is supplied with Tristel OPH Wipes. Tristel OPH Wipes are dry wipes made of a non-woven and low-linting material. Tristel OPH Wipes are intended to apply Tristel OPH Foam on the surface of ophthalmic devices and to remove residue of the foam after high level disinfection once the contact time of 2 minutes has elapsed.
Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single-use.
Minimum Recommended Concentration (MRC): ~90% v/v (~280ppm) at point of use. MRC of Tristel OPH may be verified using Tristel Test Strips.
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