# K070536: Medilas D Family Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America, Inc.
- Decided: May 21, 2007 after 84 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: 9 generations back to K943450 (1995). 31 ancestors in all.
197 later devices descend from it; 2 cite it directly.
0 of 229 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982629: Dornier Medilas D, Dornier Surgical Products, Inc. (1998) Summary page 1.
- K003993: Dornier Medilas D Skinpulse Laser System (Skinpulse), Dornier Surgical Products, Inc. (2001) Summary page 1.
- K021724: Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas D Skinpulse S Laser Systems, Dornier Medtech America, Inc. (2002) Summary page 1.
- K000072: Dornier Medilas D Skinpulse, Dornier Surgical Products, Inc. (2000) Summary page 1.
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System, Dornier Medtech America, Inc. (2002) Summary page 1.

## Most influential descendants
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K100558: Quanta Diode Laser System (2010), 68 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own

## Indications for use
The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse are indicated for use in medicine and surgery, in the following medical specialties: Urology Plastic Surgery General Surgery Dermatology Gynecology Pulmonary Surgery Gastroenterology ENT Radiology The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, are 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), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

Source page: https://510kreport.com/device/K070536
Methodology: https://510kreport.com/methodology