LNS · Class II · 21 CFR 876.5990

FDA Product Code LNS: Lithotriptor, Extracorporeal Shock-wave, Urological

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Siemens Medical Solutions USA, Inc. and Dornier Medtech America, Inc..

56
Total
56
Cleared
157d
Avg days
2001
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 139d avg (recent)

FDA 510(k) Cleared Lithotriptor, Extracorporeal Shock-wave, Urological Devices (Product Code LNS)

56 devices
1–24 of 56
Cleared Apr 29, 2026
Break Wave
K261086
Sonomotion, Inc.
Gastroenterology & Urology · 28d
Cleared Jan 12, 2026
Break Wave
K252913
Sonomotion, Inc.
Gastroenterology & Urology · 122d
Cleared Jun 18, 2025
Extracorporeal Shock Wave Lithotripter (U200)
K242922
Shenzhen Wikkon Precision Technologies Co., Ltd.
Gastroenterology & Urology · 267d
Cleared Feb 22, 2023
Delta III Pro
K221903
Dornier Medtech America, Inc.
Gastroenterology & Urology · 237d
Cleared Jan 19, 2023
LM-9300 Plus Lithotripter
K213772
Lite-Med, Inc.
Gastroenterology & Urology · 413d
Cleared Mar 30, 2021
Modulith SLX-F2
K201001
Karl Storz Endoscopy America
Gastroenterology & Urology · 348d
Cleared Sep 03, 2020
Delta III Lithotripter
K201074
Dornier Medtech America, Inc.
Gastroenterology & Urology · 134d
Cleared Jun 12, 2012
MODULTH SLK
K120769
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 04, 2008
LITHOSKOP
K070665
Siemens Medical Solutions USA, Inc.
Gastroenterology & Urology · 298d
Cleared Dec 26, 2007
STORZ MODULITH LITHOTRIPTER SLX-F2-F180
K072788
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 86d
Cleared Nov 01, 2007
MODULARIS VARIOSTAR
K070799
Siemens Medical Solutions USA, Inc.
Gastroenterology & Urology · 223d
Cleared Aug 30, 2007
STORZ SLX-F2 STORM TOUCH
K070579
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 182d
Cleared Aug 26, 2004
STORZ MODULITH, MODEL SLX-F2
K040476
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 184d
Cleared Oct 16, 2001
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d

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 510(k) Review Time - LNS Product Code

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 →