Clearance Summary
PORTASUN MODEL 600/LI SUNLAMP received FDA 510(k) clearance under submission number K852149, sponsored by Portasun , Ltd.. 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 1985-05-31.
- Submission: K852149
- Applicant / Sponsor: Portasun , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 1985-05-31
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.