K-number	K242946
Device name	HESTIA (L200-A)
Applicant	Senbitec Co., Ltd.
Product code	GEX
Device class	Class II
Decision date	Oct 3, 2025
Decision	Substantially Equivalent
Regulation	878.4810

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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HESTIA (L200-A)

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