# K160012: O-pel Laser and families of probe delivery devices

- Pathway: 510(k) (Traditional)
- Applicant: Precise Light Surgical
- Decided: Jun 2, 2016 after 150 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: 6 generations back to K936109 (1994). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051167: Revolix and Revolix JR, Allmed Systems, Inc. (2005) Summary page 6.
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001) Summary page 6.

## 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 • Laryngeallesions • 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, Uretheral Tumors and Ureteral Tumors • Ablation of Benign Prostatic Hypertrophy (BPH) • Transurethral incision of the prostrate (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 bleeding ulcers • Pancreatitas • Hemorrhoids • Cholecystectomy • Benign and Malignant Neoplasm • Angiodysplasia • Colorectal cancer • Telangiectasias • Telangiectasias of the Osler-Weber-Renu disease • Vascular Malformation • Gastritis • Esophagitis • Esophageal ulcers • Varices • Colitis • Mallory-Weiss tear • Gastric erosions Gynecology Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) • Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation, and or vessel coagulation • Soft tissue excision procedures such as excisional conization of the cervix Arthroscopy Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) • Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including: • Percutaneous Laser Disc Decompression/Discectomy • Foraminoplasty • Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery

Source page: https://510kreport.com/device/K160012
Methodology: https://510kreport.com/methodology