LNS
- Product code
- LNS
- Device name
- Lithotriptor, Extracorporeal Shock-Wave, Urological
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5990
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 56 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261086 | 2026-04-29 | Sonomotion, Inc. | Break Wave | |
| K252913 | 2026-01-12 | Sonomotion, Inc. | Break Wave | |
| K242922 | 2025-06-18 | Shenzhen Wikkon Precision Technologies… | Extracorporeal Shock Wave Lithotripter (U200) |
Official FDA classification page: LNS
Classification and pathway per current FDA publications. Data from openFDA (CC0).