K-number	K213579
Device name	Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
Applicant	Fona S.R.L
Product code	OAS
Device class	Class II
Decision date	Mar 2, 2022
Decision	Substantially Equivalent
Regulation	892.1750

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View the full FDA submission: accessdata.fda.gov

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Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

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