# K123385: Medilas H Laser Fibers

- Pathway: 510(k) (Special)
- Applicant: Dornier Medtech America, Inc.
- Decided: Dec 14, 2012 after 42 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: 7 generations back to K936109 (1994). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121938: Medilas H Rfid Laser Fiber, Dornier Medtech America, Inc. (2012) Summary page 1.
- K022544: Dornier Medilas H Laser Fiber Cables, Dornier Medtech America, Inc. (2002) Summary page 1.

## Indications for use
Dornier's Medilas H RFID Reusable Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties: Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, General Surgery.

Source page: https://510kreport.com/device/K123385
Methodology: https://510kreport.com/methodology