Clearance Summary
DEPILATOR, DERMA-I & DERMA-II received FDA 510(k) clearance under submission number K770791, sponsored by Electro-Kinetic Eng/Mfg. 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 1981-01-26.
- Submission: K770791
- Applicant / Sponsor: Electro-Kinetic Eng/Mfg
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5360
- Decision date: 1981-01-26
Classification & Regulation
This clearance is catalogued under FDA product code KCX and 21 CFR 878.5360, within the General, Plastic Surgery review panel as a Class I device.