FDA.reportPublic FDA data

510(k) K242922

Device
Extracorporeal Shock Wave Lithotripter (U200)
Applicant
Shenzhen Wikkon Precision Technologies Co., Ltd.
510(k) number
K242922
Product code
LNS
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-18
Date received
2024-09-24
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
Jack Kong
Address
Rm. 1503, 15th Floor, Bldg. A, Chuanglingtong Science And Technology Bldg., #1 Shihua Rd., Futian Bonded Are Shenzhen CN 518026 518026

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
K221903Delta III ProDornier Medtech America, Inc.2023-02-22
K213772LM-9300 Plus LithotripterLite-Med, Inc.2023-01-19
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