K-number	K221789
Device name	IRIS Pi Q switched Nd YAG laser
Applicant	Bio-Med USA, Inc.
Product code	GEX
Device class	Class II
Decision date	Aug 9, 2022
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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IRIS Pi Q switched Nd YAG laser

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