# K121570: Auriga QI

- Pathway: 510(k) (Traditional)
- Applicant: Starmedtec GmbH
- Decided: Jan 16, 2013 after 232 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 K033437 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111475: Auriga XL, Starmedtec GmbH (2011) Summary page 1.

## Most influential descendants
- K140964: Calculase II (2014), 0 descendants of its own

## Indications for use
The Auriga QI laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary,.Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery Dermiatology and Plastic Surgery Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, mucosal tissue, fatty tissue and cartilaginous tissue in therapeutic plastic, dermatologic and aesthetic surgical procedures including: - Basal Cell Carcinomas - Lesion of skin and subcutaneous tissue - Skin tags -Plantar warts - Lesions of skin and subcutaneous tissue - Port wine stains - Papillomas General Surgery Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hernostasis) including: - Appendectomy - Biopsy - Skin incision - Excision of external tumnours; and lesions - Complete or partial resection of internal organs, tumnours, lesions Gastroenterology Open and endoscopic gastroenterological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Appendectomy - Polyps - Biopsy - Gall Bladder Calculi (Lithotripsy) - Biliary/Bile duct calculi (Lithotripsy) - Ulcers - Gastric ulcers - Duodenal ulcers - Non~ bleeding ulcers - Pancreatitis - Hemorrhoids - Cholecystectomy - Benign and malignant neoplasm - Angiodysplasia - Colorectal cancer - Telangiectasias - Telangiectasias of Osler-Weber-Renu disease - Vascular malformation - Gastritis - Esophagitis - Esophageal ulcers - Varices - Colitis - Mallory-Weiss tear - Gastric Erosions

Source page: https://510kreport.com/device/K121570
Methodology: https://510kreport.com/methodology