(69 days)
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 II
- 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
- Liver 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
GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples:
- Hemorrhoidectomy
- Excision, vaporization and hemostasis 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
Aurora™ HL Diode Laser System
This document is a 510(k) premarket notification approval letter for the Aurora™ HL Diode Laser System. It does not contain any information regarding acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.
The document primarily states that the FDA has reviewed the 510(k) notification and determined the device to be substantially equivalent to legally marketed predicate devices. It then lists the indications for use of the device across various medical specialties such as ENT, Oral Surgery, Arthroscopy, Gastroenterology, General Surgery, Dermatology, Plastic Surgery, Podiatry, GI/GU, Gynecology, Neurosurgery, Ophthalmology, Pulmonary Surgery, and Urology.
Therefore, I cannot provide the requested information.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.