Clearance Summary
DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM received FDA 510(k) clearance under submission number K003916, sponsored by Scandia Manufacturing , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2002-04-15.
- Submission: K003916
- Applicant / Sponsor: Scandia Manufacturing , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5250
- Decision date: 2002-04-15
Classification & Regulation
This clearance is catalogued under FDA product code IMB and 21 CFR 890.5250, within the Physical Medicine review panel as a Class II device.