K-number	K222897
Device name	Enlight 2100
Applicant	Timpel S.A.
Product code	QEB
Device class	Class II
Decision date	Mar 7, 2023
Decision	Substantially Equivalent
Regulation	868.1505

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Source

View the full FDA submission: accessdata.fda.gov

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Enlight 2100

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