Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
K-Number: K213579 · 2022-03-02
ApplicantFona S.R.L
Decision Date2022-03-02
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph is a medical device manufactured by Fona S.R.L. It received FDA 510(k) clearance on 2022-03-02 under approval number K213579. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph?
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph is a medical device that received FDA 510(k) clearance on 2022-03-02. It is manufactured by Fona S.R.L. The 510(k) number is K213579.
When was Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph approved by the FDA?
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph received FDA 510(k) clearance on 2022-03-02, under approval number K213579.
What company makes Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph?
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph is manufactured by Fona S.R.L.
What is the FDA product code for Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph?
The FDA product code for Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph is OAS.
Other Devices by Fona S.R.L
Related Devices (Code: OAS)
K161900HYPERION X5Cefla S.C.
K160166X-MIND triumDe Gotzen S.R.L.
K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International
K160882PaX-i3D Green Premium (Model: PCT-90LH)VATECH Co., Ltd.
K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd.
K161881PreXion3D ExcelsiorPrexion Corporation
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.