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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2025-09-12 under 510(k) 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. The listed applicant is Pollogen, Ltd.. The 510(k) number is K252576.

When did Legend X Platform receive FDA 510(k) clearance?

Legend X Platform received FDA 510(k) clearance on 2025-09-12, under 510(k) number K252576.

Who is the listed applicant for Legend X Platform?

The FDA 510(k) record lists Pollogen, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Legend X Platform?

The FDA product code for Legend X Platform is GEI.

Other records listing Pollogen, Ltd. as applicant

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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.

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