Clearance Summary
TUFCOTE EPILATION PROBE received FDA 510(k) clearance under submission number K831048, sponsored by Serapis Medical Electronics, Co.. 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 1983-08-12.
- Submission: K831048
- Applicant / Sponsor: Serapis Medical Electronics, Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5350
- Decision date: 1983-08-12
Classification & Regulation
This clearance is catalogued under FDA product code KCW and 21 CFR 878.5350, within the General, Plastic Surgery review panel as a Class I device.