# K993828: Ceralas D10 810NM Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Feb 1, 2000 after 81 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Premier Laser System Aurora Diode Laser: named in the summary without a submission number
- (no number) Biolase Twilight Diode Laser: named in the summary without a submission number

## Indications for use
The attached list of indications are in addition to the already cleared indications. 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 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 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 gynecol(w. 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 Ophthalmology Retinal photocogulation Diabetic retinopathy 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

Source page: https://510kreport.com/device/K993828
Methodology: https://510kreport.com/methodology