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FDA 510(k)

Smileyscope System (Therapy Mode)

K-Number: K230825 · 2023-09-25

ApplicantSmileyscope Holding, Inc.
Decision Date2023-09-25
Product CodeQRA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Smileyscope System (Therapy Mode) is a medical device manufactured by Smileyscope Holding, Inc.. It received FDA 510(k) clearance on 2023-09-25 under approval number K230825. The device is classified under product code QRA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smileyscope System (Therapy Mode)?

Smileyscope System (Therapy Mode) is a medical device that received FDA 510(k) clearance on 2023-09-25. It is manufactured by Smileyscope Holding, Inc.. The 510(k) number is K230825.

When was Smileyscope System (Therapy Mode) approved by the FDA?

Smileyscope System (Therapy Mode) received FDA 510(k) clearance on 2023-09-25, under approval number K230825.

What company makes Smileyscope System (Therapy Mode)?

Smileyscope System (Therapy Mode) is manufactured by Smileyscope Holding, Inc..

What is the FDA product code for Smileyscope System (Therapy Mode)?

The FDA product code for Smileyscope System (Therapy Mode) is QRA.

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Related PubMed Literature

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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.

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