# K061350: Lithodiamond Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Pck Electronic Industry & Trade Co., Ltd.
- Decided: Dec 22, 2006 after 221 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011106 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011106: Stonelith, Model V5, Pck Electronic Industry and Trade Co, Ltd. (2002)
- (no number) Domier Compact Delta: named in the summary without a submission number
- (no number) Siemens Lithostar Modularis: named in the summary without a submission number
- (no number) Storz MODULITH Model SLX-F2: named in the summary without a submission number
- (no number) United Medical Systems' Piezolith 300 Lithotripter: named in the summary without a submission number

## Indications for use
To fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

Source page: https://510kreport.com/device/K061350
Methodology: https://510kreport.com/methodology