# K070799: Modularis Variostar

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 1, 2007 after 223 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) LITHOSTAR Modularis: named in the summary without a submission number

## Most influential descendants
- K101482: EM-9000 (2011), 2 descendants of its own
- K251562: OTSCneo System Set (100.03n-14n, 100.27n-31n) (2025), 0 descendants of its own
- K131721: Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1 (2014), 0 descendants of its own

## Recalls of this device
- Sep 24, 2015 · Class II · Z-0265-2016: Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.

## Indications for use
MODULARIS Variostar is a lithotripter device designed to treat urolithiasis with extracorporeal shock wave lithotripsy (ESWL) when used as part of the modular platform, MODULARIS. The device may be used in two separate configurations. Both configurations are designed to support urologic procedures within the scope of urolithiasis and may be used in a mobile-use environment. Each configuration includes: the lithotripter MODULARIS Variostar with shockwave head Cplus, a patient table, and an ECG device. One configuration would include a mobile C-arm to provide the imaging and positioning of the shockwave focus to the urinary tract stones. This configuration may be used to treat renal calyceal stones, renal pelvis stones, and ureteral stones. A second configuration would include an ultrasound system to provide the imaging and positioning of the shockwave focus to the urinary tract stones. For this configuration, the indication for use is limited to the fragmentation of kidney and upper ureteral stones only.

Source page: https://510kreport.com/device/K070799
Methodology: https://510kreport.com/methodology