AURORA DIODE LASER SYSTEM

K974586 · Premier Laser Systems, Inc. · GEX · Jul 15, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974586
• Device Name: AURORA DIODE LASER SYSTEM
• Applicant: Premier Laser Systems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SULCULAR DEBRIDEMENT - REMOVAL OF DISEASED OR INFLAMED SOFT TISSUE IN THE PERIODONTAL POCKET.

Device Story

Aurora Diode Laser System is a medical laser device used for dental procedures. It functions by delivering laser energy to target and remove diseased or inflamed soft tissue within periodontal pockets (sulcular debridement). The device is intended for use by dental professionals in a clinical setting. It serves as an additional indication to those previously cleared under 510(k) K954316. By facilitating the removal of pathological tissue, the device assists in periodontal treatment and management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Diode laser system; intended for soft tissue surgical applications. Technical specifications and materials are consistent with the previously cleared Aurora Diode Laser System (K954316).

Indications for Use

Indicated for sulcular debridement, specifically the removal of diseased or inflamed soft tissue within the periodontal pocket.

Regulatory Classification

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.

Predicate Devices

• Aurora Diode Laser System (K954316)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 1998

Ms. Lisa Mojica ·Documentation Supervisor Premier Laser Systems, Inc. 3 Morgan Irvine, California 92618

K974586/S1 Re: Trade Name: Aurora Diode Laser System Regulatory Class: II Product Code: GEX Dated: April 14, 1998 Received: Aril 21, 1998

Dear Ms. Mojica:

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 (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. Lisa Mojica

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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学院官方法

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Anrora Dinde Laser System

Indications For Use:

## (SULCULAR DEBRIDEMENT) - REMOVAL OF DISEASED OR INFLAMED SOFT TISSUE IN THE PERIODONTAL POCKET.

NOTE: This is an additional indication to the indications cleared for market release in 510(k) 954316.

(H.H.A.S.) IN NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------------------|
| Division Sign Off | |
| Division | Restorative Devices |
| 510(k) Number | K974586 |

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

Or

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|