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LNS — Lithotriptor, Extracorporeal Shock-Wave, Urological Class II

FDA Device Classification

FDA product code LNS covers "Lithotriptor, Extracorporeal Shock-Wave, Urological", a Class II medical device regulated under 21 CFR 876.5990. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LNS
Device Class
Class II
Regulation Number
876.5990
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K261086sonomotionBreak WaveApril 29, 2026
K252913sonomotionBreak WaveJanuary 12, 2026
K242922shenzhen wikkon precision technologies coExtracorporeal Shock Wave Lithotripter (U200)June 18, 2025
K221903dornier medtech americaDelta III ProFebruary 22, 2023
K213772lite-medLM-9300 Plus LithotripterJanuary 19, 2023
K201001karl storz endoscopy americaModulith SLX-F2March 30, 2021
K201074dornier medtech americaDelta III LithotripterSeptember 3, 2020
K172084dornier medtech americaDelta III LithotripterAugust 8, 2017
K170122dornier medtech americaDelta III LithotripterJune 28, 2017
K151298dornier medtech americaGemini XXP-HPJuly 30, 2015
K142561lite-medLM-9300 ELMA LithotripterMarch 20, 2015
K131817osmunda medical device consulting coEXTRACORPOREAL SHOCK WAVE LITHOTRIPTERSeptember 26, 2014
K131721comed medical systems coEXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1July 22, 2014
K132672dornier medtech americaEXTRA CORPOREAL SHOCKWAVE LITHOTRIPTERSeptember 23, 2013
K130729dornier medtech systemsEXTRA CORPOREAL SHOCKWAVE LITHOTRIPTERMay 14, 2013
K121656dornier medtech americaGEMINI LITHOTRIPTERSeptember 24, 2012
K120769karl storz endoscopy-americaMODULTH SLKJune 12, 2012
K111947direx systemsDUET MAGNAMarch 1, 2012
K103217lite-medLITE-MED LM-9200 ELMASeptember 28, 2011
K111808edap tms franceSONOLITH I-MOVEAugust 1, 2011

FDA data resources