K-number	DEN170072
Device name	Enlight 1810
Applicant	Timpel, Inc.
Product code	QEB
Device class	Class II
Decision date	Dec 20, 2018
Decision	Not Substantially Equivalent
Regulation	868.1505

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Source

View the full FDA submission: accessdata.fda.gov

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Enlight 1810

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