Tristel OPH
K-Number: K242732 · 2025-05-09
ApplicantTristel Solutions , Ltd.
Decision Date2025-05-09
Product CodeQWS
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Tristel OPH is a medical device manufactured by Tristel Solutions , Ltd.. It received FDA 510(k) clearance on 2025-05-09 under approval number K242732. The device is classified under product code QWS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tristel OPH?
Tristel OPH is a medical device that received FDA 510(k) clearance on 2025-05-09. It is manufactured by Tristel Solutions , Ltd.. The 510(k) number is K242732.
When was Tristel OPH approved by the FDA?
Tristel OPH received FDA 510(k) clearance on 2025-05-09, under approval number K242732.
What company makes Tristel OPH?
Tristel OPH is manufactured by Tristel Solutions , Ltd..
What is the FDA product code for Tristel OPH?
The FDA product code for Tristel OPH is QWS.
Related Devices (Code: QWS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.