# K984591: Dornier Medilas H/2

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Surgical Products, Inc.
- Decided: Mar 26, 1999 after 88 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: 3 generations back to K964760 (1997). 3 ancestors in all.
344 later devices descend from it; 2 cite it directly.
0 of 348 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983963: Dornier Medila H, Dornier Medtech America, Inc. (1998). Our OCR of the scanned summary read K883963, FDA’s number for Raney and Leroy-Raney Scalp Clip (New England Surgical Instrument Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Dornier Medilas H Laser System”. Summary page 2.

## Most influential descendants
- 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
- K103626: Cutera Genesisplus Laser System (2011), 121 descendants of its own

## Indications for use
The Dornier Medilas H/2 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 fbllowing medical specialties: Urology, Gastroenterology, Arthroscopy, ENT, General Surgery, Lithotripsy, Pulmonology, Gynecology

Source page: https://510kreport.com/device/K984591
Methodology: https://510kreport.com/methodology