# K992374: Aurora HL

- Pathway: 510(k) (Traditional)
- Applicant: Premier Laser Systems, Inc.
- Decided: Sep 22, 1999 after 69 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
EAR, NOSE AND THROAT AND ORAL SURGERY: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples: 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 IX Pulpotomy and pulpotomy as an adjunct to root canal therapy Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) ARTHROSCOPY: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery. Examples: Meniscectomy Synovectomy Chondromalacia GASTROENTEROLOGY: Hemostasis, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples: 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, and vaporization of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissues, and dermabrasion. Examples: Matrixectomy Excision of neuromas Excision of periungual & subungual warts Port wine stain removal Excision of plantar warts Excision of keloids Cholecystectomy Bowel resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcer Hepatobiliary Mastectomy Dermabrasion Vaporization & hemostasis of capillary hemangioma Excision, vaporization & hemostasis of abdominal tumors Excision, vaporization & hemostasis or rectal pathology Pilondial cystectomy Herniorrhaphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystectomy Thyroidectomy Resection of organs GY/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples: Hemorrhondectomy Excision, vaporization and hemostasns of rectal pathology Excision, vaporization, and hemostasis of abdominal tumors GYNECOLOGY: ablation, excision, hemostasis and vaporization of tissue. Examples: Endometrial ablation Excision or vaporization of condylomata acuminata Vaporization of CIN (cervical intraepithelelial neoplasis) Cervical conization Menorrhagia NEUROSURGERY: Hemostasis Hemostasis for myangioma OPHTHALMOLOGY: Incision, excision and vaporization of tissue surrounding the eye and orbit Photocoagulation of the retina PULMONARY SURGERY: Hemostasis, vaporization, and excision of tissue. Examples: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction UROLOGY: Hemostasis, vaporization and excision of tissues. Examples: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia

Source page: https://510kreport.com/device/K992374
Methodology: https://510kreport.com/methodology