# K022544: Dornier Medilas H Laser Fiber Cables

- Pathway: 510(k) (Special)
- Applicant: Dornier Medtech America, Inc.
- Decided: Aug 21, 2002 after 20 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K980685: Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers, Lumenis, Inc. (1998). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K121938: Medilas H Rfid Laser Fiber (2012), 3 descendants of its own
- K152591: Medilas H RFID Laser Fibers (2015), 1 descendant of its own
- K090776: Megapulse Laser System and Fibers (2009), 1 descendant of its own
- K161771: Medilas H Laser Fibers (2016), 0 descendants of its own
- K122368: Waterlase Iplus All Tissue Laser (2013), 0 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 Laser is indicated for use in medicine and surgery, in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.

Source page: https://510kreport.com/device/K022544
Methodology: https://510kreport.com/methodology