# K082263: Ceralas E 980NM Diode Laser, Models E15/980 and E30/980

- Pathway: 510(k) (Special)
- Applicant: Biolitec, Inc.
- Decided: Oct 24, 2008 after 77 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: 16 generations back to K943450 (1995). 185 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032863: Ceralas D 980 Diode Laser System, Models D15, D25, D50, Biolitec, Inc. (2004) Summary page 1.
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 1.
- K081015: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 1.

## Most influential descendants
- K093087: BWF-5 Medical Laser Series (2010), 0 descendants of its own

## Indications for use
The Ceralas E15/980, E30/980 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 E15/980, E30/980 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, cardiothoracic surgery, and ophthalmology. This Ceralas E15/980, E30/980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue) and 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 Hemiorapphy 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 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 CardiothoracicSurgery: Incision, excision, vaporization, ablation, hemostasis, or 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/K082263
Methodology: https://510kreport.com/methodology