K-number	K152032
Device name	ELUMI 810 + 980 Soft Tissue Laser
Applicant	Azena Medical, LLC
Product code	GEX
Device class	Class II
Decision date	Sep 16, 2015
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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ELUMI 810 + 980 Soft Tissue Laser

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