K-number	K242227
Device name	GENEO X ELITE
Applicant	Pollogen, Ltd.
Product code	PAY
Device class	Class II
Decision date	Oct 12, 2025
Decision	Substantially Equivalent
Regulation	878.4420

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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GENEO X ELITE

Everything you need for a 510(k) submission. Nothing you don't.