# K122159: Dornier Medilas H30 Solvo

- Pathway: 510(k) (Special)
- Applicant: Dornier Medtech America, Inc.
- Decided: Feb 1, 2013 after 196 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: 7 generations back to K936109 (1994). 32 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061455: Dornier Medilas H 20 Laser, Dornier Medtech America, Inc. (2006) Summary page 1.

## Most influential descendants
- K180350: Dornier Medilas H Solvo 35 Laser (2018), 0 descendants of its own
- K130344: Dornier Medilas Uropulse (2013), 0 descendants of its own

## Indications for use
The Solvo is intended to be used for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endloscopic 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 Solvo is indicated for use in medicine and surgery, in the following medical specialties: Arthroscopy Urology Lithotri psy Pulmonology Gastroenterology Gynecology ENT. General Surgery

Source page: https://510kreport.com/device/K122159
Methodology: https://510kreport.com/methodology