# K103654: Vela XL - Pathway: 510(k) (Traditional) - Applicant: Starmedtec GmbH - Decided: Apr 6, 2011 after 112 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 K070476 (2007). 1 ancestor in all. 14 later devices descend from it; 2 cite it directly. 0 of 16 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K070476: Revolix 120, Allmed Systems, Inc. (2007) Summary page 1. ## Most influential descendants - K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) (2019), 12 descendants of its own - K211401: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2021), 7 descendants of its own - K221306: SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories (2023), 4 descendants of its own - K242191: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2024), 3 descendants of its own - K261221: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2026), 1 descendant of its own ## Indications for use The vela® 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 and hard 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 (BNI) - 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) - Holmium Laser Enucleation of the prostate (HoLEP) - Holmium Laser Ablation of the prostate (HoLap) - Bladder/Renal Calculi (Lithotripsy) - Condylomas - Lesions or external genitalia 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 Thoracic and Pulmonary Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue - Laryngeal lesions - Airway obstructions including carcinoma - Polyps and granuloma - Palliation of obstructing carcinoma of the tracheobroncial tree Gynaecology Open and endoscopic gynaecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis): - Intra-uterine treatment of sub mucous fibroids - Benign endometrial polyps and uterine septum by incision, excision and or vessel coagulation - Soft tissue excision procedures such as excisional conisation of the cervix ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Endonasal / sinus surgery - Partial turbinectomy - Polypectomy - Dacryocystorhinostomy - Frontal sinustomy - Ethmoidectomy - Maxillary antrostomy - Functional endoscopic sinus surgery - Lesions or tumnours (oral, nasal, glossal, pharyngeal or laryngeal) - Tonsillectomy - Adenoidectomy 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 (hard tissue) including: - Basal Cell Carcinomas - Lesion of skin and subcutaneous tissue - Skin tags - Plantar warts General Surgery Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Cholecystectomy - Lysis of adhesion - Appendectomy - Biopsy - Skin incision - Tissue dissection - Excision of external tumnours and lesions - Complete or partial resection of internal organs, tumnours, lesions - Mastectomy - Hepatectomy - Pancreatectomy - Splenectomy - Thyroidectomy - Parathyroidectomy - Herniorrhaphy - Tonsillectomy - Lymphadenectomy - Partial nephrectomy - Pilonidal Cystectomy - Resection of lipoma - Debridement of decubitus ulcer - Hemorrhoids - Debridement of statis ulcer Arthroscopy Arthroscopic/orthopaedic surgery (excision, ablation, and coagulation of soft and cartilaginous (hard) tissue): Ablation of soft and cartilaginous (hard) tissue in minimal invasive spinal surgery including - Percutaneous laser disc decompressionldisectomy - Foraminoplasty - Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery Source page: https://510kreport.com/device/K103654 Methodology: https://510kreport.com/methodology