(15 days)
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
BluLaze™ Blue Light Emitting Diode (LED) System
This document is an FDA 510(k) clearance letter for the BluLaze™ Blue Light Emitting Diode (LED) System. It grants marketing approval for the device but does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The letter from August 20, 1999, states that the device is substantially equivalent to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a previously cleared device. However, it does not mandate a new clinical study or the establishment of new acceptance criteria for this specific device in this document.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on the performance characteristics or clinical study results that would typically be included in such a request.
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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 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.
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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.
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
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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
§ 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.