# K080959: Dornier Medilas D 30 Laser, Medilas D 1064

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America, Inc.
- Decided: Jun 27, 2008 after 85 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: 11 generations back to K943450 (1995). 142 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070536: Medilas D Family Lasers, Dornier Medtech America, Inc. (2007) Summary page 1.
- K051996: Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30, Diomed, Ltd. (2005)
- K964760: Dornier Medilas Fiber Tome Laser, Dornier Medtech America, Inc. (1997) Summary page 1.
- K063828: Diomed Delta 25, Diomed, Ltd. (2007) Summary page 1.
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002) Summary page 1.

## Most influential descendants
- K181510: Echolaser X4 (2018), 3 descendants of its own
- K213594: Echolaser X4 (2022), 1 descendant of its own
- K261964: Echolaser X4 (2026), 0 descendants of its own
- K260632: Laser Thermal Therapy Kit (2026), 0 descendants of its own

## Indications for use
The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, ENT, Radiology. The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).

Source page: https://510kreport.com/device/K080959
Methodology: https://510kreport.com/methodology