# K121938: Medilas H Rfid Laser Fiber

- Pathway: 510(k) (Special)
- Applicant: Dornier Medtech America, Inc.
- Decided: Aug 1, 2012 after 30 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: 6 generations back to K936109 (1994). 32 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022544: Dornier Medilas H Laser Fiber Cables, Dornier Medtech America, Inc. (2002) Summary page 1.
- K050108: Sureflex and Accuflex Laser Lithotripsy Fibers, Innovaquartz (2005) Summary page 1.
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001) Summary page 1.

## Most influential descendants
- K152591: Medilas H RFID Laser Fibers (2015), 1 descendant of its own
- K161771: Medilas H Laser Fibers (2016), 0 descendants of its own
- K123385: Medilas H Laser Fibers (2012), 0 descendants of its own

## Indications for use
Dornier's Medilas H RFID 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/K121938
Methodology: https://510kreport.com/methodology