Name: Predicase
Price: 199 USD

K-number	K994116
Device name	LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)
Applicant	Aesculap-Meditec North America
Product code	GEX
Device class	Class II
Decision date	Jun 1, 2000
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)

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