Name: Predicase
Price: 199 USD

K-number	K153389
Device name	Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
Applicant	In Light Wellness Systems, Inc.
Product code	ILY
Device class	Class II
Decision date	Mar 30, 2016
Decision	Substantially Equivalent
Regulation	890.5500

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Source

View the full FDA submission: accessdata.fda.gov

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Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)

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