Clearance Summary
UV 8001K, PUVA 800, PUVA 180/200 1000 received FDA 510(k) clearance under submission number K841795, sponsored by Waldmann Lighting 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 1984-08-30.
- Submission: K841795
- Applicant / Sponsor: Waldmann Lighting Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 1984-08-30
Classification & Regulation
This clearance is catalogued under FDA product code KGL and 21 CFR 878.4630, within the General, Plastic Surgery review panel as a Class II device.