# K111475: Auriga XL - Pathway: 510(k) (Traditional) - Applicant: Starmedtec GmbH - Decided: Sep 28, 2011 after 124 days - Product code: GEX (Powered Laser Surgical Instrument) - Device class: 2 - Regulation: 21 CFR 878.4810 - Recalls of this device: 14 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K033437 (2004). 1 ancestor in all. 5 later devices descend from it; 2 cite it directly. 0 of 7 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K033437: Sphinx Laser Systems, Allmed Systems, Inc. (2004) Summary page 1. ## Most influential descendants - K131987: Multipulse Hoplus (2014), 2 descendants of its own - K161257: MultiPulse HoPLUS (2017), 1 descendant of its own - K121570: Auriga QI (2013), 1 descendant of its own - K253633: Holmium Laser Therapeutic Apparatus (HZ-40) (2026), 0 descendants of its own - K140964: Calculase II (2014), 0 descendants of its own ## Recalls of this device - Apr 8, 2019 · Class II · Z-1396-2019: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the sc - Apr 8, 2019 · Class II · Z-1395-2019: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the sc - Apr 8, 2019 · Class II · Z-1393-2019: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the sc - Apr 8, 2019 · Class II · Z-1397-2019: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the sc - Apr 8, 2019 · Class II · Z-1392-2019: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the sc - Apr 8, 2019 · Class II · Z-1391-2019: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the sc - Apr 8, 2019 · Class II · Z-1394-2019: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the sc - Apr 8, 2019 · Class II · Z-1399-2019: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the sc - Apr 8, 2019 · Class II · Z-1398-2019: Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the sc - Sep 22, 2017 · Class II · Z-0897-2018: Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes o - Sep 22, 2017 · Class II · Z-0898-2018: Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes o - Sep 30, 2014 · Class II · Z-0049-2015: Product is not cleared for use with lasers other than the Auriga XL system - Sep 30, 2014 · Class II · Z-0050-2015: Product is not cleared for use with lasers other than the Auriga XL system - Sep 30, 2014 · Class II · Z-0051-2015: Product is not cleared for use with lasers other than the Auriga XL system ## Indications for use The Auriga XL 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 Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Strictures of urethra and ureter - Bladder Neck Incisions (BNJ) - Ablation and resecetion of Bladder Tumors, Uretheral Tumors and Ureteral Tumors - Ablation of Benign Prostatic Hyperplasia (BPH) - Transurethral incision of prostate (TUIP) - Holmium Laser Resection of the prostate (HoLRP) - Holmiumn Laser Enucleation of the prostate (HoLEP) - Holmium Laser Ablation of the prostate (HoLap) - Bladder/Renal calculi (Lithotripsy) - Condylomas - Lesions or external genitalia - Lithotripsy - Percutaneous Urinary Lithtripsy - Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones - Endoscopic fragemnation of kidney calculi - Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterolopy 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 Arthroscopv Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilangenous tissue) in small and large joints of the body excluding the spine but including: - Ligament and tendon Release - Countouring and sculpting of articular surfaces - Capsulectomnie in the knee - Chondreoplasty in the knee - Debridement of inflamed synovial tissue - Chondromalacia ablation - Chondtromalcia and tears - Plica removal - Meniscectomy - Loose body debridement - Lateral retineacular release Ablation of soft, cartilanginous and bony tissue in minimal invasive spinal surgery including - Percutaneous laser disc decompression/discectomy of the L4-5 and L5-S1 lumbar discs, including forminoplasty - Percutaneous cervical disc decompression/discectomy - Percutaneous thoracic disc decompression/discectomy Thoracic and Pulmonary Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue Gynaecology Open and endoscopic/laparoscopic gynaecoiogical surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis). ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue and cartilage) including: - Endonasal / sinus surgery - Partial turbinectomny - Polypectomny - Dacryocystorhinostomny - Frontal sinustomny - Ethmoidectomny - Maxillary antrostomny - Functional endoscopic sinus surgery Dermatology and Plastic Surgery Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, muscosal tissue, fatty tissue and cartilaginous tissue in therapeutic plastic, dermatologid 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 hemostasis) including: - Appendectomy - Biopsy - Skin incision - Excision of external tumours and lesions - Complete or partial resection of internal organs, tumnours, lesions Source page: https://510kreport.com/device/K111475 Methodology: https://510kreport.com/methodology