Clearance Summary
ML24000 UVA-1 PHOTOTHERAPY UNIT received FDA 510(k) clearance under submission number K103708, sponsored by The Daavlin Distributing Company. 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 2011-02-22.
- Submission: K103708
- Applicant / Sponsor: The Daavlin Distributing Company
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 2011-02-22
Classification & Regulation
This clearance is catalogued under FDA product code FTC and 21 CFR 878.4630, within the General, Plastic Surgery review panel as a Class II device.