FDA Product Code ILY: Lamp, Infrared, Therapeutic Heating
Leading manufacturers include Light Tree Ventures Europe B.V., Cure Point Therapeutics, Inc. and Gigaalaser Company , Ltd..
FDA 510(k) Cleared Lamp, Infrared, Therapeutic Heating Devices (Product Code ILY)
About Product Code ILY - Regulatory Context
510(k) Submission Activity
229 total 510(k) submissions under product code ILY since 1985, with 229 receiving FDA clearance (average review time: 168 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
Recent submissions under ILY have taken an average of 272 days to reach a decision - up from 167 days historically. Manufacturers should account for longer review timelines in current project planning.
ILY devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →