Chrysalis Intelligence · Product Codes · LNS

LNS · Lithotriptor, Extracorporeal Shock-Wave, Urological

Gastroenterology, Urology · 7 clearances · 5 unique sponsors

Device class
Class II
Regulation 876.5990
Total clearances
7
2020-09-03 → 2026-04-29
Last 12 months
2
Unique sponsors
5
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5990
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Sonomotion, Inc. 2 2 2026-04-29
Dornier Medtech America, Inc. 2 0 2023-02-22
Lite-Med, Inc. 1 0 2023-01-19
Karl Storz Endoscopy America 1 0 2021-03-30
Shenzhen Wikkon Precision Technologies Co., Ltd. 1 0 2025-06-18
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
50590 CPT High Extracorporeal shock wave lithotripsy; standard ESWL urological procedure
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-29 K261086 Sonomotion, Inc. Break Wave
2026-01-12 K252913 Sonomotion, Inc. Break Wave
2025-06-18 K242922 Shenzhen Wikkon Precision Technologies Co., Ltd. Extracorporeal Shock Wave Lithotripter (U200)
2023-02-22 K221903 Dornier Medtech America, Inc. Delta III Pro
2023-01-19 K213772 Lite-Med, Inc. LM-9300 Plus Lithotripter
2021-03-30 K201001 Karl Storz Endoscopy America Modulith SLX-F2
2020-09-03 K201074 Dornier Medtech America, Inc. Delta III Lithotripter