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FDA 510(k)

Extracorporeal Shock Wave Lithotripter (U200)

K-Number: K242922 · 2025-06-18

ApplicantShenzhen Wikkon Precision Technologies Co., Ltd.
Decision Date2025-06-18
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Extracorporeal Shock Wave Lithotripter (U200) is a medical device manufactured by Shenzhen Wikkon Precision Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-06-18 under approval number K242922. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Extracorporeal Shock Wave Lithotripter (U200)?

Extracorporeal Shock Wave Lithotripter (U200) is a medical device that received FDA 510(k) clearance on 2025-06-18. It is manufactured by Shenzhen Wikkon Precision Technologies Co., Ltd.. The 510(k) number is K242922.

When was Extracorporeal Shock Wave Lithotripter (U200) approved by the FDA?

Extracorporeal Shock Wave Lithotripter (U200) received FDA 510(k) clearance on 2025-06-18, under approval number K242922.

What company makes Extracorporeal Shock Wave Lithotripter (U200)?

Extracorporeal Shock Wave Lithotripter (U200) is manufactured by Shenzhen Wikkon Precision Technologies Co., Ltd..

What is the FDA product code for Extracorporeal Shock Wave Lithotripter (U200)?

The FDA product code for Extracorporeal Shock Wave Lithotripter (U200) is LNS.

Related Clinical Trials

NCT07615920 HILT vs ESWT in Supraspinatus Tendinitis NOT_YET_RECRUITING NCT06531746 Effect of Extracorporeal Shock Wave on Electrophysiological Changes and Pain in Patients With Lower Cross Syndrome COMPLETED NCT07594223 Efficacy of Activator Trigger Point and Shock Wave Therapy on Pain and Function in Active Upper Trapezius Trigger Points: A Randomized Controlled Study NOT_YET_RECRUITING NCT03873259 Intraoperative Assessment of of Burst Wave Lithotripsy (BWL) RECRUITING NCT07320807 Effects of Extracorporeal Shock Wave Therapy After Flexor Tendon Injury RECRUITING NCT07563764 Low-Energy Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome RECRUITING

Related Devices (Code: LNS)

K172084Delta III LithotripterDornier Medtech America, Inc. K170122Delta III LithotripterDornier Medtech America K201074Delta III LithotripterDornier Medtech America, Inc. K201001Modulith SLX-F2Karl Storz Endoscopy America K221903Delta III ProDornier Medtech America, Inc. K213772LM-9300 Plus LithotripterLite-Med, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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