K-number	K201743
Device name	ClarifEye R1.0, ClarifEye Needle
Applicant	Philips Medical Systems Nederlands B.V.
Product code	OWB
Device class	Class II
Decision date	Feb 23, 2021
Decision	Substantially Equivalent
Regulation	892.1650

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View the full FDA submission: accessdata.fda.gov

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ClarifEye R1.0, ClarifEye Needle

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