# K982629: Dornier Medilas D

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Surgical Products, Inc.
- Decided: Sep 14, 1998 after 48 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: 1 generation back to K955758 (1996). 2 ancestors in all.
698 later devices descend from it; 6 cite it directly.
0 of 701 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964760: Dornier Medilas Fiber Tome Laser, Dornier Medtech America, Inc. (1997) Summary page 1.
- K955758: Indigo Medical Model Idl 830E, Indigo Medical, Inc. (1996) Summary page 1.

## Most influential descendants
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System (2002), 695 descendants of its own
- 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

## Indications for use
The Dornier Medilas D 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 D is indicated for use in medicine and surgery, in the following medical specialties: Urology Pulmonary Surgery Plastic Surgery Gastroenterology General Surgery ENT Dermatology Radiology Gynecology

Source page: https://510kreport.com/device/K982629
Methodology: https://510kreport.com/methodology