Clearance Summary
Airborne Phototherapy Light received FDA 510(k) clearance under submission number K160238, sponsored by International Biomedical. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-06-14.
- Submission: K160238
- Applicant / Sponsor: International Biomedical
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 2016-06-14
Classification & Regulation
This clearance is catalogued under FDA product code LBI and 21 CFR 880.5700, within the General Hospital review panel as a Class II device.