# K021724: Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas D Skinpulse S Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America, Inc.
- Decided: Aug 19, 2002 after 87 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: 2 generations back to K955758 (1996). 6 ancestors in all.
305 later devices descend from it; 2 cite it directly.
0 of 312 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963969: Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power Options : 25, 20, 15 & 10 Watts) Indigo Fib, Indigo Medical, Inc. (1997) Summary page 2.
- 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
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 descendants of its own
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own
- K071295: 100W Ceralas D 980NM Diode Laser (2007), 230 descendants of its own
- K072106: 150W Ceralas D 980NM Diode Laser (2007), 229 descendants of its own
- K070536: Medilas D Family Lasers (2007), 197 descendants of its own

## Indications for use
The Dornier Diode Laser family, Medilas™ D Fibertom Laser (“Medilas D”), Medilas™ D SkinPulse™ (“SkinPulse”) and Medilas D SkinPulse™ S (“SkinPulse S“), with ITT Light Guide or Light Guide with bare fiber (fiber diameter 400pm or 600pm) 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 28-85cc. The Dornier Diode Laser family, Medilas™ D Fibertom Laser (“Medilas D”), Medilas™ D SkinPulse™ (“SkinPulse”) and Medilas D SkinPulse™ S (“SkinPulse S“),are intended 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 SkinPulse™and SkinPulse™ S lasers are also for use for the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.

Source page: https://510kreport.com/device/K021724
Methodology: https://510kreport.com/methodology