LNS · Class II · 21 CFR 876.5990

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

Leading manufacturers include Direx Systems Corp., Dornier Medtech America, Inc. and KARL STORZ Endoscopy-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 Aug 08, 2017
Delta III Lithotripter
K172084
Dornier Medtech America, Inc.
Gastroenterology & Urology · 29d
Cleared Jun 28, 2017
Delta III Lithotripter
K170122
Dornier Medtech America
Gastroenterology & Urology · 166d
Cleared Jul 30, 2015
Gemini XXP-HP
K151298
Dornier Medtech America
Gastroenterology & Urology · 76d
Cleared Mar 20, 2015
LM-9300 ELMA Lithotripter
K142561
Lite-Med, Inc.
Gastroenterology & Urology · 190d
Cleared Sep 26, 2014
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K131817
Osmunda Medical Device Consulting Co., Ltd.
Gastroenterology & Urology · 463d
Cleared Jul 22, 2014
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1
K131721
Comed Medical Systems Co., Ltd.
Gastroenterology & Urology · 405d
Cleared Sep 23, 2013
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
K132672
Dornier Medtech America
Gastroenterology & Urology · 27d
Cleared May 14, 2013
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
K130729
Dornier Medtech Systems
Gastroenterology & Urology · 57d
Cleared Sep 24, 2012
GEMINI LITHOTRIPTER
K121656
Dornier Medtech America, Inc.
Gastroenterology & Urology · 111d
Cleared Jun 12, 2012
MODULTH SLK
K120769
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 01, 2012
DUET MAGNA
K111947
Direx Systems Corp.
Gastroenterology & Urology · 237d
Cleared Aug 01, 2011
SONOLITH I-MOVE
K111808
Edap Tms France
Gastroenterology & Urology · 35d
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 Oct 20, 2006
INTEGRA SL
K062147
Direx Systems Corp.
Gastroenterology & Urology · 85d

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 →