Name: Predicase
Price: 199 USD

K-number	K221623
Device name	FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
Applicant	Gme German Medical Engineering GmbH
Product code	GEX
Device class	Class II
Decision date	Mar 10, 2023
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm

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