Opera Evo

Quanta System Spa

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K202041
Device name
Opera Evo
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-07-23
Decision date
2020-10-15
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cuttingOtherVascular treatmentSkin tightening
Primary application
Surgical cutting
Classification source
AI classified

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 specialties 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
• Functional 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
• Herniorrhap

Intended 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 Traditionalities including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, General Surgery and Arthroscopy.

Device Description

The Opera Evo laser device includes a diode laser that emits a wavelength of 1940 nm and includes a diode laser that emits a wavelength of 1470 nm, with a combined cumulated laser output power up to 40W. Laser radiation is delivered to the patient via a quartz optical fiber having a diameter up to 1000 μm. The main subsystems of the device are the two diode lasers, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch.

Summary parsed at:2026-06-01 05:48:26 UTC

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