BLULAZE

K992620 · Premier Laser Systems, Inc. · GEX · Aug 20, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992620
• Device Name: BLULAZE
• Applicant: Premier Laser Systems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Curing of all light cured bonding materials Curing of pit and fissure sealants (unfilled resins) Curing for all classes of composite restorations (filled resins) Curing for endodontic composite cores Curing composite cements for porcelain facings and inlays Curing of light activated periodontal splint material Curing of light activated prosthetic reline and repair material Curing use in the fabrication of laboratory indirect light activated and provisional restorations Teeth Whitening

Device Story

BluLaze™ is a blue light-emitting diode (LED) system used in dental settings. Device emits blue light to initiate polymerization of light-cured dental materials; also used for teeth whitening. Operated by dental professionals. Provides targeted light energy to dental substrates to facilitate curing of resins, cements, and restorative materials. Benefits include efficient, rapid hardening of dental materials and cosmetic teeth whitening.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Blue light-emitting diode (LED) system. Operates via light emission for polymerization. Standalone dental device.

Indications for Use

Indicated for dental professionals for the curing of light-activated dental materials (bonding agents, sealants, composite resins, cements, splinting, and prosthetic materials) and for teeth whitening procedures.

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.

Submission Summary (Full Text)

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

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 stylized eagle with three stripes forming its wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 1999

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

Re: K992620

Trade Name: BluLaze™ Blue Light Emitting Diode (LED) System Regulatory Class: II Product Code: GEX Dated: July 7, 1999 Received: August 5, 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 (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.

{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 [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.

Thunell W. Payan

Sor 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 _ 1

510(k) Number (if known): _ LGG 26 20

Device Name: BluLaze™ Blue Light Emitting Diode (LED) System

Indications for Use:

Curing of all light cured bonding materials

Curing of pit and fissure sealants (unfilled resins)

Curing for all classes of composite restorations (filled resins)

Curing for endodontic composite cores

Curing composite cements for porcelain facings and inlays

Curing of light activated periodontal splint material

Curing of light activated prosthetic reline and repair material

Curing use in the fabrication of laboratory indirect light activated and provisional restorations

Teeth Whitening

NOTE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Theodore M. Payson. for, J20

sion Sign-Off) sion of General Res

Prescription Use (Per 21 CFR 801.109) Or

Over-The-Counter Use