Name: Predicase
Price: 199 USD

K-number	K120231
Device name	EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
Applicant	Biolitec Medical Devices, Inc.
Product code	GEX
Device class	Class II
Decision date	Apr 24, 2012
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)

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