Name: Predicase
Price: 199 USD

K-number	K083500
Device name	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
Applicant	Dornier Medtech America, Inc.
Product code	GEX
Device class	Class II
Decision date	Feb 12, 2009
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE

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