Clearance Summary
REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) received FDA 510(k) clearance under submission number K093100, sponsored by Shenzhen Comfort Technology Co., 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 2009-11-24.
- Submission: K093100
- Applicant / Sponsor: Shenzhen Comfort Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5110
- Decision date: 2009-11-24
Classification & Regulation
This clearance is catalogued under FDA product code IMC and 21 CFR 890.5110, within the Physical Medicine review panel as a Class II device.