FDA Product Code FTC: Light, Ultraviolet, Dermatological
Leading manufacturers include Daavlin Distributing Co., Shenzhen Honpal Optoelectronic Technology Co., Ltd. and Psoria-Shield, Inc..
FDA 510(k) Cleared Light, Ultraviolet, Dermatological Devices (Product Code FTC)
About Product Code FTC - Regulatory Context
510(k) Submission Activity
272 total 510(k) submissions under product code FTC since 1976, with 272 receiving FDA clearance (average review time: 77 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FTC have taken an average of 93 days to reach a decision - up from 76 days historically. Manufacturers should account for longer review timelines in current project planning.
FTC devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →