O-pel Laser and families of probe delivery devices

Precise Light Surgical

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

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
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

Predicate devices

2

K160012 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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