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 the device name listed in this FDA 510(k) record. The listed applicant is Tristel Solutions , Ltd.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) 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. The listed applicant is Tristel Solutions , Ltd.. The 510(k) number is K242732.
When did Tristel OPH receive FDA 510(k) clearance?
Tristel OPH received FDA 510(k) clearance on 2025-05-09, under 510(k) number K242732.
Who is the listed applicant for Tristel OPH?
The FDA 510(k) record lists Tristel Solutions , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tristel OPH?
The FDA product code for Tristel OPH is 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.