# K202041: Opera Evo

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Oct 15, 2020 after 84 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: 21 generations back to K943450 (1995). 340 ancestors in all.
No later device cites it as a predicate yet.
0 of 341 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133891: Multipulse TM+1470, Asclepion Laser Technologies GmbH (2015) Summary page 6.

## Indications for use
Opera Evo laser device and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical Traditionalties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, General Surgery and Arthroscopy. Urology: Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: • Urethral Strictures • Bladder Neck Incisions (BNI) • Ablation and Resection of Bladder Tumors, Urethral and Ureteral Tumors • Ablation of Benign Prostatic Hypertrophy (BPH) • Transurethral Incision of the Prostate (TUIP) • Laser Resection of the Prostate • Laser Enucleation of the Prostate • Laser Ablation of the Prostate • Condylomas • Lesions of external genitalia ENT: Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: • Endonasal/sinus Surgery • Partial turbinectomy • Polypectomy • Dacryocystorhinostomy • Frontal sinusotomy • Ethmoidectomy • Maxillary antrostomy • Functionale endoscopic sinus surgery • Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal area • Tonsillectomy • Adenoidectomy Gastroenterology: Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: • Polyps • Biopsy • Gall Bladder calculi • Biliary/Bile duct calculi • Ulcers • Gastric ulcers • Duodenal ulcers • Non-bleeding ulcers • Pancreatitis • Hemorrhoids • Cholecystectomy • Benign and Malignant Neoplasm • Angiodysplasia • Colorectal cancer • Telangiectasias • Telangiectasias of the Osler-Weber-Rendu disease (OWRD) • Vascular Malformation • Gastritis • Esophagitis • Esophageal ulcers • Varices • Colitis • Mallory-Weiss tear • Gastric erosion Thoracic and Pulmonary Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue including: • Laryngeal lesions Gynecology: Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: • Intra-uterine treatment of submucous fibroids • Benign endometrial polyps and uterine septum by incision, excision, ablation and vessel coagulation • Soft tissue excision procedures such as excisional conization of the cervix 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 tumors and lesions • Complete or partial resection of internal organs, tumors and 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: Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) Ablation of soft, cartilaginous and bony tissue in Minimal invasive Spinal Surgery including: • Percutaneous Laser Disc Decompression/Discectomy • Foraminoplasty • Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasi ve spinal surgery

Source page: https://510kreport.com/device/K202041
Methodology: https://510kreport.com/methodology