Clearance Summary
MICROCYN SCAR MANAGEMENT HYDROGEL received FDA 510(k) clearance under submission number K131672, sponsored by Oculus Innovative Sciences. 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 2013-11-15.
- Submission: K131672
- Applicant / Sponsor: Oculus Innovative Sciences
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 2013-11-15
Classification & Regulation
This clearance is catalogued under FDA product code PFP and 21 CFR 878.4025, within the General, Plastic Surgery review panel as a Class I device.