GENEO X ELITE
K-Number: K242227 · 2025-10-12
ApplicantPollogen, Ltd.
Decision Date2025-10-12
Product CodePAY
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
GENEO X ELITE is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2025-10-12 under approval number K242227. The device is classified under product code PAY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GENEO X ELITE?
GENEO X ELITE is a medical device that received FDA 510(k) clearance on 2025-10-12. It is manufactured by Pollogen, Ltd.. The 510(k) number is K242227.
When was GENEO X ELITE approved by the FDA?
GENEO X ELITE received FDA 510(k) clearance on 2025-10-12, under approval number K242227.
What company makes GENEO X ELITE?
GENEO X ELITE is manufactured by Pollogen, Ltd..
What is the FDA product code for GENEO X ELITE?
The FDA product code for GENEO X ELITE is PAY.
Other Devices by Pollogen, Ltd.
Related Devices (Code: PAY)
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.