# K983963: Dornier Medila H

- Pathway: 510(k) (Special)
- Applicant: Dornier Medtech America, Inc.
- Decided: Nov 25, 1998 after 19 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: 2 generations back to K964760 (1997). 2 ancestors in all.
346 later devices descend from it; 2 cite it directly.
0 of 349 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 2.

## Most influential descendants
- K984591: Dornier Medilas H/2 (1999), 344 descendants of its own
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices (2001), 342 descendants of its own
- K083616: Patholase Family of Pinpointe and Pinpointe  Footlaser ND: Yag Lasers (2009), 136 descendants of its own
- K083215: Incisive Family of Inpulse ND:Yag Lasers (2009), 136 descendants of its own
- K093545: Pinpointe Footlaser Model 6W, 30W, 100W (2010), 122 descendants of its own

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

Source page: https://510kreport.com/device/K983963
Methodology: https://510kreport.com/methodology