Clearance Summary
SPERTILITE PHOTOTHERAPY LAMP received FDA 510(k) clearance under submission number K862608, sponsored by Cooper-Hewitt Electric 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 1986-08-06.
- Submission: K862608
- Applicant / Sponsor: Cooper-Hewitt Electric Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 1986-08-06
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.