# K072682: 50W Ceralas D 1950NM Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Apr 18, 2008 after 210 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: 1 generation back to K033423 (2004). 3 ancestors in all.
194 later devices descend from it; 3 cite it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033423: Revolix Laser Systems, Allmed Systems, Inc. (2004) Summary page 1.
- K051167: Revolix and Revolix JR, Allmed Systems, Inc. (2005) Summary page 1.
- K070476: Revolix 120, Allmed Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K082230: Vectra Plus Laser System and Accessories (2010), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K100558: Quanta Diode Laser System (2010), 68 descendants of its own

## Indications for use
Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: · Urethral strictures · Bladder neck incisions · 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 the 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 Pancreatitis 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 Thoracic/Pulmonary Surgery Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including · Laryngeal lesions · Airway obstruction including carcinoma * Polyps and granulomas · Palliation of obstructing carcinomas of the tracheobronchial tree Gynecology Open and endoscopic 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 or vessel coagulation Soft tissue excision procedures such as excisional conization of the cervix Ear, Nose and Throat (Otolaryngology) Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) 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/Plastic Surgery Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue in therapeutic plastic, dermatologic and aesthetic procedures including: · Basal Cell carcinomas · Lesions of the skin and subcutaneous tissue * Skin tags * Plantar warts Arthroscopy Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) * Ablation of soft and cartilaginous tissue in minimally invasive spinal surgery including: : Percutaneous laser disc decompression/discectomy --- Foraminoplasty Ablation and coagulation of soft vascular and non vascular tissue General Surgery Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: * Cholecystecomy * Lysis of adhesions • 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 ulcers * Hemorrhoids * Debridement of statis ulcers · Biopsy

Source page: https://510kreport.com/device/K072682
Methodology: https://510kreport.com/methodology