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510(k) K242922

Extracorporeal Shock Wave Lithotripter (U200) by Shenzhen Wikkon Precision Technologies Co., Ltd. — Product Code LNS

K242922 is an FDA 510(k) premarket notification submitted by Shenzhen Wikkon Precision Technologies Co., Ltd. for the device "Extracorporeal Shock Wave Lithotripter (U200)". The FDA issued a decision of Substantially Equivalent on June 18, 2025. 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
June 18, 2025
Date Received
September 24, 2024
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

  • K261086 — Break Wave (April 29, 2026)
  • K252913 — Break Wave (January 12, 2026)
  • 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)
  • K142561 — LM-9300 ELMA Lithotripter (March 20, 2015)

FDA data resources