Manufacturer
Precise Light SurgicalO-pel Laser and families of probe delivery devices
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K160012
- Device name
- O-pel Laser and families of probe delivery devices
- Company
- Precise Light Surgical
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-01-04
- Decision date
- 2016-06-02
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The O-pel laser and families of probe delivery devices 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 Arthroscopy, Urology, ENT, Dermatology, Plastic Surgery, General Surgery, Gastroenterology, Thoracic and Pulmonary and Gynecology. 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 * Tonsillectomy * Adenoidectomy Dermatology and Plastic Surgery Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: * Basal cell carcinomas * Lesions 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 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 * Biopsy 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 Granulomas * Palliation of obstructing carcinomas of the tracheobronchial tree 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 Tumors and Ureteral Tumors * Ablation of Benign Prostatic Hypertrophy (BPH) * Transurethral incision of the prostate (TUIP) * Laser resection of the prostate (HoLRP) * Laser enucleation of the prostate (HoLEP) * Laser ablation of the prostate (HoLAP) * Condylomas * Lesions of external genitalia Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: * Appendectomy * Polyps * Biopsy * Gall Bladder calculi * Biliary/Bile duct calculi * Ulcers * Gastric ulcers * Duodenal ulcers * Non bl
Intended Use
The O-pel laser and families of probe delivery devices 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 Arthroscopy, Urology, ENT, Dermatology, Plastic Surgery, General Surgery, Gastroenterology, Thoracic and Pulmonary and Gynecology.
Device Description
The O-pel laser is an infrared laser system with an output wavelength of approximately 2um. The O-pel laser and families of probe delivery devices (O-pel laser system) have an Intended Use of cutting and coagulating tissue, specifically incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue. The O-pel laser system is comprised of the following components: a laser console, control and display panel, a fiber port for delivery systems, a footswitch, and a variety of fiber optic (probe) delivery devices.
Summary parsed at:2026-06-01 06:05:42 UTC
