Clearance Summary
ROBI COMBI received FDA 510(k) clearance under submission number K930859, sponsored by Epilady 2000, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-02-28.
- Submission: K930859
- Applicant / Sponsor: Epilady 2000, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5960
- Decision date: 1994-02-28
Classification & Regulation
This clearance is catalogued under FDA product code LJL and 21 CFR 880.5960, within the General Hospital review panel as a Class I device.