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510(k) K131817

EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER by Osmunda Medical Device Consulting Co., Ltd. — Product Code LNS

K131817 is an FDA 510(k) premarket notification submitted by Osmunda Medical Device Consulting Co., Ltd. for the device "EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER". The FDA issued a decision of Substantially Equivalent on September 26, 2014. 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
September 26, 2014
Date Received
June 20, 2013
Clearance Type
Traditional
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