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

Device Description

Aurora™ HL Diode Laser System

AI/ML Overview

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1999

Ms. Beth A. Roberts Regulatory Specialist Premier Laser Systems 3 Morgan Irvine, California 92618

Re: K992374

Trade Name: Aurora™ HL Diode Laser System Regulatory Class: II Product Code: GEX Dated: July 7, 1999 Received: July 15, 1999

Dear Ms. Roberts:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

Page 2 - Ms. Beth A. Roberts

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

to coelle

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page __ 1 of _3

510(k) Number (if known): K992374

Device Name: Aurora™ HL Diode Laser System

Indications for Use:

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

Prescription Use (Per 21 CFR 801.109)

(Division Sian Off Division of General Restorative D 510(k) Number

{3}------------------------------------------------

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 .

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Seneral Restorative De 510(k) Number

{4}------------------------------------------------

Excision and vaporization of condyloma .
Lesions of external genitalia .

NOTE:

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

bcsefo

(Division Sign-Off) Division of General Restorative Devices 510(k) Number .

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

923

Regulation Number and Section

§ 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.