Name: Predicase
Price: 199 USD

K-number	K112031
Device name	ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
Applicant	Alma Lasers, Inc.
Product code	GEX
Device class	Class II
Decision date	Sep 13, 2011
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION

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