Extracorporeal Shock Wave Lithotripter (U200)
FDA 510(k) K242922 · Shenzhen Wikkon Precision Technologies Co., Ltd.
510(k) numberK242922
Submission
- Device name
- Extracorporeal Shock Wave Lithotripter (U200)
- Applicant
- Shenzhen Wikkon Precision Technologies Co., Ltd.
Shenzhen, CN - Received
- September 24, 2024
- Decision date
- June 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5990
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LNS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261086 | Break WaveLNS · Special | Sonomotion, Inc. | 04/29/2026SE |
| K252913 | Break WaveLNS · Traditional | Sonomotion, Inc. | 01/12/2026SE |
| K221903 | Delta III ProLNS · Traditional | Dornier Medtech America, Inc. | 02/22/2023SE |
| K213772 | LM-9300 Plus LithotripterLNS · Traditional | Lite-Med, Inc. | 01/19/2023SE |
| K201001 | Modulith SLX-F2LNS · Traditional | Karl Storz Endoscopy America | 03/30/2021SE |
| K201074 | Delta III LithotripterLNS · Traditional | Dornier Medtech America, Inc. | 09/03/2020SE |
| K172084 | Delta III LithotripterLNS · Special | Dornier Medtech America, Inc. | 08/08/2017SE |
| K170122 | Delta III LithotripterLNS · Traditional | Dornier Medtech America | 06/28/2017SE |
| K151298 | Gemini XXP-HPLNS · Traditional | Dornier Medtech America | 07/30/2015SE |
| K142561 | LM-9300 ELMA LithotripterLNS · Abbreviated | Lite-Med, Inc. | 03/20/2015SE |
Questions and answers
When was Extracorporeal Shock Wave Lithotripter (U200) cleared by the FDA?
Extracorporeal Shock Wave Lithotripter (U200) (K242922) received a 510(k) decision of Substantially Equivalent on June 18, 2025, 267 days after the submission was received.
What is the product code of K242922?
The FDA product code is LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5990.