Name: Predicase
Price: 199 USD

K-number	K163079
Device name	HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System
Applicant	Healthlight, LLC
Product code	ILY
Device class	Class II
Decision date	Jun 13, 2017
Decision	Substantially Equivalent
Regulation	890.5500

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Source

View the full FDA submission: accessdata.fda.gov

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HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System

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