K-number	K180140
Device name	ProFlex Laser Fibers
Applicant	Innovaquartz, LLC
Product code	GEX
Device class	Class II
Decision date	Apr 20, 2018
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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ProFlex Laser Fibers

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