K-number	K251334
Device name	NEW DOUBLO 2.0
Applicant	Hironic Co., Ltd.
Product code	GEI
Device class	Class II
Decision date	Sep 29, 2025
Decision	Substantially Equivalent
Regulation	878.4400

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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NEW DOUBLO 2.0

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