FDA.reportPublic FDA data

510(k) K213772

Device
LM-9300 Plus Lithotripter
Applicant
Lite-Med, Inc.
510(k) number
K213772
Product code
LNS
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-19
Date received
2021-12-02
Regulation
876.5990
Classification name
Lithotriptor, Extracorporeal Shock-Wave, Urological
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Walt Hsu
Address
9th Floor, 49 Dongxing Rd., Xinyi District Taipei TW 11070 11070

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LNS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261086Break WaveSonomotion, Inc.2026-04-29
K252913Break WaveSonomotion, Inc.2026-01-12
K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.2025-06-18
K221903Delta III ProDornier Medtech America, Inc.2023-02-22
K201001Modulith SLX-F2Karl Storz Endoscopy America2021-03-30
K201074Delta III LithotripterDornier Medtech America, Inc.2020-09-03
K172084Delta III LithotripterDornier Medtech America, Inc.2017-08-08
K170122Delta III LithotripterDornier Medtech America2017-06-28
K151298Gemini XXP-HPDornier Medtech America2015-07-30
K142561LM-9300 ELMA LithotripterLite-Med, Inc.2015-03-20
K131817EXTRACORPOREAL SHOCK WAVE LITHOTRIPTEROsmunda Medical Device Consulting Co., Ltd.2014-09-26
K131721EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1Comed Medical Systems Co., Ltd.2014-07-22
K132672EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTERDornier Medtech America2013-09-23
K130729EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTERDornier Medtech Systems2013-05-14
K121656GEMINI LITHOTRIPTERDornier Medtech America, Inc.2012-09-24