FDA Product Code LFL: Instrument, Ultrasonic Surgical
Ultrasonic energy has transformed minimally invasive surgery by providing a single tool for simultaneous cutting and coagulation. FDA product code LFL covers ultrasonic surgical instruments.
These devices use high-frequency mechanical vibrations to cut tissue and coagulate blood vessels simultaneously, with minimal thermal spread and smoke generation compared to electrosurgical devices. They are widely used in laparoscopic, robotic, and open surgical procedures.
LFL devices are reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Integra LifeSciences Corporation, Ethicon Endo-Surgery, LLC and Stryker Corporation.
FDA 510(k) Cleared Instrument, Ultrasonic Surgical Devices (Product Code LFL)
About Product Code LFL - Regulatory Context
510(k) Submission Activity
157 total 510(k) submissions under product code LFL since 1980, with 157 receiving FDA clearance (average review time: 123 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 10 in the prior period.
FDA Review Time
Recent submissions under LFL have taken an average of 184 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.
LFL devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →