K-number	K110079
Device name	SPPHINE PLUS STM 3W DIODE LASER
Applicant	Den-Mat Holdings, LLC
Product code	GEX
Device class	Class II
Decision date	Feb 10, 2011
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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SPPHINE PLUS STM 3W DIODE LASER

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