K-number	K230825
Device name	Smileyscope System (Therapy Mode)
Applicant	Smileyscope Holding, Inc.
Product code	QRA
Device class	Class II
Decision date	Sep 25, 2023
Decision	Substantially Equivalent
Regulation	890.5800

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View the full FDA submission: accessdata.fda.gov

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Smileyscope System (Therapy Mode)

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