# K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America, Inc.
- Decided: Oct 25, 2002 after 266 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: 8 generations back to K943450 (1995). 28 ancestors in all.
695 later devices descend from it; 5 cite it directly.
0 of 724 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012398: Diomed 15 Diode Laser, Diomed, Ltd. (2002)
- K982629: Dornier Medilas D, Dornier Surgical Products, Inc. (1998) Summary page 1.
- K000072: Dornier Medilas D Skinpulse, Dornier Surgical Products, Inc. (2000) Summary page 1.
- K003993: Dornier Medilas D Skinpulse Laser System (Skinpulse), Dornier Surgical Products, Inc. (2001) Summary page 1.

## Most influential descendants
- K030186: Polris LV (2003), 680 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K051214: Aluma Skin Renewal System (2005), 476 descendants of its own
- K052324: Polaris LV, Lva Applicator (2005), 456 descendants of its own
- K041959: Polaris DS/Comet (2004), 301 descendants of its own

## Indications for use
Dornier MedTech America, Inc. is requesting the expansion of the indications for use for the Dornier Diode Laser family previously cleared under K982629, K000072, KO03993 and K021724. The Dornier Diode Laser family, MedilasTM D Fibertom Laser (“Medilas D”), MedilasrM D SkinulseTM(“SkinPulse”) and MedilasTMD SkinPulseTMS (“SkinPulse Sf),are intended for use in the treatment of symptoms due to urinary oufflow 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 28-85cc and for 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 a handpiece). The SkinPulseTMand SkinPulseTMS lasers are also for use for the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair. The Dornier Diode Family Lasers are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology. This premarket notification requests clearance for the additional indication as stated: The Dornier diode family lasers, Medilas D Fibertom Laser (“Medilas D”), Medilas D SkinPulse (“SkinPulse”)and Medilas D SkinPulse S (“SkinPulse S’) are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K020339
Methodology: https://510kreport.com/methodology