FDA Product Code LBI: Unit, Neonatal Phototherapy
Leading manufacturers include Gerium Medical, Ltd. and Thera B Medical Products.
FDA 510(k) Cleared Unit, Neonatal Phototherapy Devices (Product Code LBI)
About Product Code LBI - Regulatory Context
510(k) Submission Activity
71 total 510(k) submissions under product code LBI since 1976, with 71 receiving FDA clearance (average review time: 134 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LBI have taken an average of 237 days to reach a decision - up from 131 days historically. Manufacturers should account for longer review timelines in current project planning.
LBI devices are reviewed by the General Hospital panel. Browse all General Hospital devices →