# K981718: Dornier Medilas H

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Surgical Products, Inc.
- Decided: Jul 17, 1998 after 63 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: 1 generation back to K964760 (1997). 1 ancestor in all.
348 later devices descend from it; 3 cite it directly.
0 of 350 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964760: Dornier Medilas Fiber Tome Laser, Dornier Medtech America, Inc. (1997) Summary page 2.
- (no number) Coherent’s VersaPulse 2.1: named in the summary without a submission number

## Most influential descendants
- K983963: Dornier Medila H (1998), 346 descendants of its own
- 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

## Indications for use
The Dornier Medilas H 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, colonoscopes, or for open surgery for contact or noncontact surgery with or without hand pieces for use in coagulation, incision/exiciions, ablation and vaporization of soft tissue. The laser is indicated for use in medicine and surgery, in the following specialties: Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery.

Source page: https://510kreport.com/device/K981718
Methodology: https://510kreport.com/methodology