K-number	DEN240047
Device name	Allix5
Applicant	Clairity, Inc.
Product code	SEZ
Device class	Class II
Decision date	May 30, 2025
Decision	Not Substantially Equivalent
Regulation	892.8500

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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Allix5

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