FDA 510(k)

Smileyscope System (Therapy Mode)

K-Number: K230825 · 2023-09-25

Decision Date2023-09-25

Product CodeQRA

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Smileyscope System (Therapy Mode) is the device name listed in this FDA 510(k) record. The listed applicant is Smileyscope Holding, Inc.. It received FDA 510(k) clearance on 2023-09-25 under 510(k) 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. The listed applicant is Smileyscope Holding, Inc.. The 510(k) number is K230825.

When did Smileyscope System (Therapy Mode) receive FDA 510(k) clearance?

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

Who is the listed applicant for Smileyscope System (Therapy Mode)?

The FDA 510(k) record lists Smileyscope Holding, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: QRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254004VRNTCognifisense, Inc.K251519RelieVRx (Pico G3)Appliedvr K243417RelieVRxAppliedvr K230814VRNTCognifisense, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.