# K081015: Ceralas D 980NM Diode Laser, Models D15 and D25

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Jul 8, 2008 after 90 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). 184 ancestors in all.
34 later devices descend from it; 6 cite it directly.
0 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 1.
- K072034: Diode Medical Laser Family, Models 4, 6, 30, Quanta System Spa (2007) Summary page 1.

## Most influential descendants
- K094049: Stlase Diode Laser (2010), 23 descendants of its own
- K111689: Stlase (2012), 22 descendants of its own
- K163128: Epic Pro (2017), 16 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K212734: Diode laser therapy device (2023), 5 descendants of its own

## Indications for use
The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery, and ophthalmology. This Ceralas D 980 is specifically indicated for laser assisted lipolysis. Specific Indications for Use: Ear, Nose and Throat, and Oral Surgery: 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 * Tonsillectomy * Thyroidectomy * Vocal cord polypectomy * Hemiglossectomy * Tracheal stenosis * Oral cavity lesions Dental Applications: Intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: * 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 * Vestibuloplasty * Excision of lesions * Exposure of unerupted/partially erupted teeth * Leukoplakia * Removal of hyperplastic tissues * Treatment of aphthous ulcers * Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) * Pulpotomy * Pulpotomy as an adjunct to root canal therapy * Light activation of bleaching materials for teeth whitening 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 * Phototcoagulation of teleangectasia of the legs and face * Photocoagulation of vascular lesions of the face and extremities 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 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. Example includes: Hemostasis in conjunction with menigiomas 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 Cardiothoracic Surgery: Incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue, including cardiac tissues. Laser Assisted Lipolysis Ophthalmology: The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology. Examples include: * Open Dacryocystorhinostomy * Endonasal Dacryocystorhinostomy * Blepharoplasty * Oculoplastics * Tumor excision and biopsy * Eyelid reconstruction

Source page: https://510kreport.com/device/K081015
Methodology: https://510kreport.com/methodology