K-number	K091169
Device name	ELITE MPX LASER SYSTEM WITH CRYO C
Applicant	Cynosure, Inc.
Product code	GEX
Device class	Class II
Decision date	May 13, 2009
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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ELITE MPX LASER SYSTEM WITH CRYO C

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