K-number	K181662
Device name	Iridex TruFocus LIO Premiere
Applicant	Iridex Corporation
Product code	GEX
Device class	Class II
Decision date	Sep 5, 2018
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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Iridex TruFocus LIO Premiere

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