Clearance Summary
EPILATOR, BLEND-MODEL EB-200 & ET-1 received FDA 510(k) clearance under submission number K811503, sponsored by Rcx-Western, 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 1981-07-10.
- Submission: K811503
- Applicant / Sponsor: Rcx-Western, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5350
- Decision date: 1981-07-10
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.