FDA Product Code LNS: Lithotriptor, Extracorporeal Shock-wave, Urological
Leading manufacturers include Sonomotion, Inc., Dornier Medtech America, Inc. and Shenzhen Wikkon Precision Technologies Co., Ltd..
FDA 510(k) Cleared Lithotriptor, Extracorporeal Shock-wave, Urological Devices (Product Code LNS)
About Product Code LNS - Regulatory Context
510(k) Submission Activity
56 total 510(k) submissions under product code LNS since 2001, with 56 receiving FDA clearance (average review time: 157 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for LNS submissions have been consistent, averaging 139 days recently vs 158 days historically.
LNS devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →