Clearance Summary
HIGH FREQUENCY NEEDLE-TYPE EPILATOR received FDA 510(k) clearance under submission number K864291, sponsored by Multi-Channel Epilator. 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 1986-12-24.
- Submission: K864291
- Applicant / Sponsor: Multi-Channel Epilator
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5350
- Decision date: 1986-12-24
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.