Clearance Summary
FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT received FDA 510(k) clearance under submission number K050695, sponsored by Daavlin Distributing Co.. 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 2005-04-19.
- Submission: K050695
- Applicant / Sponsor: Daavlin Distributing Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 2005-04-19
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.