K-number	K230905
Device name	OrthoPulse 2.0E (OPi2E-100)
Applicant	Biolux Technology GmbH
Product code	PLH
Device class	Class II
Decision date	Jun 9, 2023
Decision	Substantially Equivalent
Regulation	872.5470

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View the full FDA submission: accessdata.fda.gov

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OrthoPulse 2.0E (OPi2E-100)

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