AURORA

K981379 · Premier Laser Systems, Inc. · GEX · Nov 23, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981379
• Device Name: AURORA
• Applicant: Premier Laser Systems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pulpotomy as an adjunct to root canal therapy

Device Story

Aurora Diode Laser System is a medical laser device used in dental procedures. It functions as an adjunct to root canal therapy specifically for performing pulpotomies. The device is operated by dental professionals in a clinical setting. By delivering laser energy, it assists in the treatment of dental pulp tissue. The output is used by the clinician to facilitate the pulpotomy procedure, potentially improving procedural efficiency or outcomes compared to traditional methods.

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 dental surgical applications. Technical specifications and materials are consistent with the previously cleared device (K954316).

Indications for Use

Indicated for patients requiring pulpotomy as an adjunct to root canal therapy.

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

• K954316

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 23 1998

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

Re: K981379 Trade Name: Aurora Diode Laser System Regulatory Class: II Product Code: GEX Dated: September 08, 1998 Received: September 11, 1998

Dear Ms. Soper:

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 (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. Soper

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,

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

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Page __ 1__ of __ 1

510(k) Number (if known): _K983179

Device Name: Aurora Diode Laser System

Indications for Use:

Pulpotomy

## Pulpotomy as an adjunct to root canal therapy

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Or

(Division Sign-Off)
Division of General Restorative Devices K981379
510(k) Number

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use