K-number	K110897
Device name	CORTEX CO2 / ER:YAG LASER SYSTEM
Applicant	Sandstone Medical Technologies, LLC
Product code	GEX
Device class	Class II
Decision date	Jul 1, 2011
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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CORTEX CO2 / ER:YAG LASER SYSTEM

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