K-number	K252178
Device name	MAGENTIQ-COLO (ME-APDS)
Applicant	Magentiq Eye, Ltd.
Product code	QNP
Device class	Class II
Decision date	Oct 3, 2025
Decision	Substantially Equivalent
Regulation	876.1520

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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MAGENTIQ-COLO (ME-APDS)

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