Legend X Platform
K-Number: K252576 · 2025-09-12
ApplicantPollogen, Ltd.
Decision Date2025-09-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Legend X Platform is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2025-09-12 under approval number K252576. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Legend X Platform?
Legend X Platform is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Pollogen, Ltd.. The 510(k) number is K252576.
When was Legend X Platform approved by the FDA?
Legend X Platform received FDA 510(k) clearance on 2025-09-12, under approval number K252576.
What company makes Legend X Platform?
Legend X Platform is manufactured by Pollogen, Ltd..
What is the FDA product code for Legend X Platform?
The FDA product code for Legend X Platform is GEI.
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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.