# K050824: 100W Ceralas D 980 Laser System, Model D100

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Aug 10, 2005 after 132 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
No predicates in its family tree.
305 later devices descend from it; 9 cite it directly.
0 of 306 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 50W Ceralas D 980 Diode Laser System: named in the summary without a submission number
- (no number) Ceralas F100 Nd:YAG Laser System: named in the summary without a submission number

## Most influential descendants
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 descendants of its own
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own
- K060114: Vectra Laser System (2006), 233 descendants of its own
- K071295: 100W Ceralas D 980NM Diode Laser (2007), 230 descendants of its own
- K072106: 150W Ceralas D 980NM Diode Laser (2007), 229 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 100W 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 bleedin * Excision and vaporization of colorectal ca * 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 homeostasis 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 * Phototcoagulation of teleangectasia 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 homeostasis 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 Gynecology Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: * Endometrial ablation * Excision or vaporization of condylomata acuminata * Vaporization of cervical intraepithelial neoplasia * Cervical conization * Menorrhagia Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: homeostasis 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 (he endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Source page: https://510kreport.com/device/K050824
Methodology: https://510kreport.com/methodology