Clearance Summary
Smileyscope System (Therapy Mode) received FDA 510(k) clearance under submission number K230825, sponsored by Smileyscope Holding, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-09-25.
- Submission: K230825
- Applicant / Sponsor: Smileyscope Holding, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 890.5800
- Decision date: 2023-09-25
Classification & Regulation
This clearance is catalogued under FDA product code QRA and 21 CFR 890.5800, within the Neurology review panel as a Class II device.