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.
ARTHROSCOPY: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery.
GASTROENTEROLOGY: Hemostasis, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy.
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.
GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues.
GYNECOLOGY: ablation, excision, hemostasis and vaporization of tissue.
NEUROSURGERY: Hemostasis.
OPHTHALMOLOGY: Incision, excision and vaporization of tissue surrounding the eye and orbit; Photocoagulation of the retina.
PULMONARY SURGERY: Hemostasis, vaporization, and excision of tissue.
UROLOGY: Hemostasis, vaporization and excision of tissues.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Aurora™ SL Diode Laser System, indicating that the device is substantially equivalent to previously marketed devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The content primarily focuses on the regulatory aspects of the device, including:

Trade Name: Aurora™ SL Diode Laser System
Regulatory Class: II
Product Code: GEX
Manufacturer: Premier Laser Systems, Inc.
Clearance Date: November 18, 1999
Indications for Use: A comprehensive list across various medical specialties (ENT & Oral Surgery, Arthroscopy, Gastroenterology, General Surgery, Dermatology & Plastic Surgery, Podiatry, GI/GU, Gynecology, Neurosurgery, Ophthalmology, Pulmonary Surgery, Urology).

Since the provided text is a 510(k) clearance letter and not a clinical study report or a summary of performance data, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, or MRMC studies. Such details are typically found in the technical documentation submitted with the 510(k) application, but they are not present in this clearance letter itself.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1999

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

Re: K993285 Trade Name: Aurora™ SL Diode Laser System Regulatory Class: II Product Code: GEX Dated: September 28, 1999 Received: September 30, 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 prìor 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.

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 your device to proceed to the market.

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Page 2 - Ms. Beth A. Roberts

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,

P. Collen Jr.

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ 1 __ of _ 3

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Aurora™ SL Diode Laser System

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 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

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

Prescription Use
(Per 21 CFR 801.109)

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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 General Restorative Devices, K993285
510(k) Number

. Ş

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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)

Hcolly B

(Division Sigh-Off) Division of General Restorative Devices K993285 510(k) Number

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use_ 1

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.