Clearance Summary
SoftSpot received FDA 510(k) clearance under submission number K212045, sponsored by Pediametrix, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2021-09-28.
- Submission: K212045
- Applicant / Sponsor: Pediametrix, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2021-09-28
Classification & Regulation
This clearance is catalogued under FDA product code QQO and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.