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510(k) K201074

Device
Delta III Lithotripter
Applicant
Dornier MedTech America, Inc.
510(k) number
K201074
Product code
LNS  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-03
Date received
2020-04-22
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
John Hoffer
Address
1155 Roberts Blvd., Suite 100 Kennesaw GA US 30144 30144

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
K213772LM-9300 Plus LithotripterLite-Med, Inc.2023-01-19
K201001Modulith SLX-F2Karl Storz Endoscopy America2021-03-30
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

Legacy Summary#

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FDA Review#

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