# K072106: 150W Ceralas D 980NM Diode Laser

- Pathway: 510(k) (Special)
- Applicant: Biolitec, Inc.
- Decided: Aug 30, 2007 after 30 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: 15 generations back to K943450 (1995). 166 ancestors in all.
229 later devices descend from it; 6 cite it directly.
0 of 396 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050824: 100W Ceralas D 980 Laser System, Model D100, Biolitec, Inc. (2005) Summary page 1.
- K071295: 100W Ceralas D 980NM Diode Laser, Biolitec, Inc. (2007) Summary page 1.
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene, Intermedic Arfran, SA (2006) Summary page 1.
- K060114: Vectra Laser System, Xintec Corporation, Dba, (2006) Summary page 1.

## Most influential descendants
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own
- K083682: 180W Cerelas D 980NM Diode Laser, Model D180 (2009), 121 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

## Indications for use
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 150W Ceralas D980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein. The device is specifically indicated for use as follows: Ear, Nose and Throat and Oral Surgery (Otolaryngology) Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include: Removal of benign lesions from the ear, nose and throat Excision and vaporization of vocal cord nodules and polyps Incision and excision of carcinoma in situ Ablation and vaporization of hyperkeratosis Excision of carcinoma of the larynx Laryngeal papillomectomy Excision and vaporization of herpes simplex I and II Neck dissection Arthroscopy Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include: Menisectomy Synovectomy Chondromalacia Gastroenterology Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: Hemostasis of upper and lower GI bleeding Excision and vaporization of colorectal carcinoma Excision of polyps General Surgery, Dermatology, Plastic Surgery and Podiatry Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcers Hepatobiliary tumors Mastectomy Dermabrasion Vaporization and hemostasis of capillary hemangioma Excision, vaporization and hemostasis of abdominal tumors Excision, vaporization and hemostasis of rectal pathology Pilonidal cystectomy Herniorapphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystectomy Thyroidectomy Resection of organs Debridement of wounds Photocoagulation otteleangectasia of the legs and face Photocoagulation of vascular lesions of the face and extremities Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. Treatment of reticular veins and branch varicosities Urology Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia Vaporization of the prostate to treat benign prostatic hyperplasia (BPH) Gynecology Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: Endometrial ablation Excision or vaporization of condylomata acuminate Vaporization of cervical intraepithelial neoplasia Cervical conization Menorrhagia Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas Cardiac Surgery Hemostasis and coagulation of soft tissue, including cardiac tissue. Pulmonary Surgery Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction Endoscopic pulmonary applications Dental Applications Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening. Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Source page: https://510kreport.com/device/K072106
Methodology: https://510kreport.com/methodology