# K062081: Lithogold

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Regeneration Technologies, Inc.
- Decided: Nov 2, 2006 after 104 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K970019: Menicon Z Bifocal Design Lens/Menicon Z Trifocal Design Lens, Menicon U.S.A., Inc. (1997). Our reading of the summary gave K970019, FDA’s number for Menicon Z Bifocal Design Lens/Menicon Z Trifocal Design Lens (Menicon U.S.A., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “HealthTronics LithoTron”. Kept off the family tree.

## Indications for use
The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).

Source page: https://510kreport.com/device/K062081
Methodology: https://510kreport.com/methodology