# K130344: Dornier Medilas Uropulse

- Pathway: 510(k) (Special)
- Applicant: Dornier Medtech America, Inc.
- Decided: Mar 21, 2013 after 38 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K936109 (1994). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122159: Dornier Medilas H30 Solvo, Dornier Medtech America, Inc. (2013) Summary page 1.
- K061455: Dornier Medilas H 20 Laser, Dornier Medtech America, Inc. (2006) Summary page 1.
- K100228: Versapulse Model P20 Laser System, Lumenis, Inc. (2010) Summary page 1.

## Indications for use
The Uropulse is intended to be used for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Uropulse is indicated for use in medicine and surgery, in the following medical specialties: Arthroscopy Urology Lithotripsy Pulmonology Gastroenterology Gynecology ENT General Surgery

Source page: https://510kreport.com/device/K130344
Methodology: https://510kreport.com/methodology