Name: Predicase
Price: 199 USD

K-number	K210033
Device name	Laser Treatment System, Model: NYX and Grace
Applicant	Canadian Pioneer Medical Technology Corporation
Product code	GEX
Device class	Class II
Decision date	Feb 26, 2021
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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Laser Treatment System, Model: NYX and Grace

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