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510(k) K130729

EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER by Dornier Medtech Systems — Product Code LNS

K130729 is an FDA 510(k) premarket notification submitted by Dornier Medtech Systems for the device "EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER". The FDA issued a decision of Substantially Equivalent on May 14, 2013. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2013
Date Received
March 18, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Extracorporeal Shock-Wave, Urological
Device Class
Class II
Regulation Number
876.5990
Review Panel
GU
Submission Type

Other clearances for product code LNS

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  • K252913 — Break Wave (January 12, 2026)
  • K242922 — Extracorporeal Shock Wave Lithotripter (U200) (June 18, 2025)
  • K221903 — Delta III Pro (February 22, 2023)
  • K213772 — LM-9300 Plus Lithotripter (January 19, 2023)
  • K201001 — Modulith SLX-F2 (March 30, 2021)
  • K201074 — Delta III Lithotripter (September 3, 2020)
  • K172084 — Delta III Lithotripter (August 8, 2017)
  • K170122 — Delta III Lithotripter (June 28, 2017)
  • K151298 — Gemini XXP-HP (July 30, 2015)

FDA data resources