Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Wikkon Precision Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) 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. The listed applicant is Shenzhen Wikkon Precision Technologies Co., Ltd.. The 510(k) number is K242922.

When did Extracorporeal Shock Wave Lithotripter (U200) receive FDA 510(k) clearance?

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

Who is the listed applicant for Extracorporeal Shock Wave Lithotripter (U200)?

The FDA 510(k) record lists Shenzhen Wikkon Precision Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02652078Shockwave Therapy in Lower Limb Intermittent Calf ClaudicationACTIVE_NOT_RECRUITINGNCT03873259Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)RECRUITINGNCT05907239Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular OriginRECRUITINGNCT06041958Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on LymphoedemaRECRUITINGNCT06214286ESWT Imorove Pain and Function in Carpal TunnelCOMPLETEDNCT06531746Effect of Extracorporeal Shock Wave on Electrophysiological Changes and Pain in Patients With Lower Cross SyndromeCOMPLETED

Related Devices (Code: LNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261086Break WaveSonomotion, Inc.K252913Break WaveSonomotion, Inc.K221903Delta III ProDornier Medtech America, Inc.K213772LM-9300 Plus LithotripterLite-Med, Inc.K201001Modulith SLX-F2Karl Storz Endoscopy AmericaK201074Delta III LithotripterDornier Medtech America, 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.

↑