K-number	K161046
Device name	Laser Helmet LH40-EVO
Applicant	Theradome, Inc.
Product code	OAP
Device class	Class II
Decision date	May 12, 2016
Decision	Substantially Equivalent
Regulation	890.5500

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View the full FDA submission: accessdata.fda.gov

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Laser Helmet LH40-EVO

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