Model note · Lithotripter (ESWL)
STORZ MEDICAL MODULITH SLX-F2 Lithotripter
The MODULITH SLX-F2 is an electromagnetic extracorporeal shock wave lithotripter for kidney and ureteral stones. A cylindrical electromagnetic source with a parabolic reflector focuses shock waves through a water filled coupling cushion onto the stone, with in line localisation, and the operator can switch between a small high pressure focus and a larger focus during treatment. It is also offered as a transportable system for mobile lithotripsy services.
The model
Maker, model and type.
- Maker
- STORZ MEDICAL AG (US: Karl Storz Endoscopy-America)
- Model
- MODULITH SLX-F2 Lithotripter
- Device type
- Lithotripter (ESWL)
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Shock wave principle | Electromagnetically repelled membrane (cylindrical source) with shock waves focused by a parabolic reflector; coupled through a water filled rubber cushion | Source |
| Dual focus | 6 x 28 mm or 9 x 50 mm, selectable during treatment | Source |
| Penetration depth | 0 to 165 mm (service provider brief) | Source |
| Size and weight | 169 x 89 x 124 cm; 659 kg | Source |
| Localisation | In line localisation; black and white ultrasound (colour Doppler unit available) | Source |
| Indications | Non invasive fragmentation of stones in the kidney and upper, middle and lower ureter, adults and children 3 years or over | Source |
| Standards | IEC 60601-1, 60601-1-2, 60601-2-36 (lithotripsy equipment), IEC 61846; software level of concern moderate | Source |
| FDA clearance | K201001 (March 2021), predicate SLX-F2 F180 (K072788, 2007); product code LNS, 21 CFR 876.5990 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Sources
Where this note comes from.
- FDA 510(k) K201001 summary, MODULITH SLX-F2
- FDA 510(k) K072788 summary, MODULITH SLX-F2 F180
- ForTec Medical MODULITH SLX-F2 product brief (mobile service provider)
- openFDA MAUDE problem counts, MODULITH brand
Not covered: STORZ MEDICAL's own pages gave no technical data and no operator or service manual was found, so energy levels, shock rates, error messages and maintenance intervals are missing. Focus, depth, size and weight come from a mobile service provider's brief; a search snippet suggested STORZ quotes up to 180 mm depth with an optional source, but that was not confirmed. openFDA has no MODULITH recall records.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
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