K-number	K241416
Device name	Ion 3D
Applicant	SurGenTec, LLC
Product code	MRW
Device class	Class U
Decision date	Jun 17, 2024
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Ion 3D

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