Clearance Summary
IDSS SLC received FDA 510(k) clearance under submission number K133413, sponsored by Black Diamond Video. 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 2014-01-07.
- Submission: K133413
- Applicant / Sponsor: Black Diamond Video
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2014-01-07
Classification & Regulation
This clearance is catalogued under FDA product code FTA and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.