# K061455: Dornier Medilas H 20 Laser

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America, Inc.
- Decided: Aug 1, 2006 after 68 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: 6 generations back to K936109 (1994). 31 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981718: Dornier Medilas H, Dornier Surgical Products, Inc. (1998) Summary page 1.
- K043012: Omnipulse Mini, Model 2120, Trimedyne, Inc. (2004) Summary page 1.
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001) Summary page 1.

## Most influential descendants
- K122159: Dornier Medilas H30 Solvo (2013), 2 descendants of its own
- K180350: Dornier Medilas H Solvo 35 Laser (2018), 0 descendants of its own
- K130344: Dornier Medilas Uropulse (2013), 0 descendants of its own
- K080525: Cook Odyssey Holmium Laser System, Model 30W (2008), 0 descendants of its own

## Indications for use
The Dornier Medilas H 20 Laser 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 Dornier Medilas H 20 Laser 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/K061455
Methodology: https://510kreport.com/methodology