LogoFDA 510(k) Search
K Number
K971118
Device Name
ARAGO
Manufacturer
PREMIER LASER SYSTEMS, INC.
Date Cleared
1997-12-16

(270 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
K983654
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Curing of all light cured bonding materials.
  2. Curing of pit and fissure sealants (unfilled resins).
  3. Curing for all classes of composite restorations (filled resins).
  4. Curing for endodontic composite cores.
  5. Curing composite cements for porcelain facings and inlays.
  6. Curing of light activated periodontal splint material.
  7. Curing of light activated prosthetic reline and repair material.
  8. Curing used in the fabrication of laboratory indirect light activated restorations and provisional restorations.
  9. Illumination purposes for the adjunctive use in caries detection.
  10. Illumination purposes for the adjunctive use for endodontic orifice location.
  11. Light activation for bleaching materials for teeth whitening.
Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter for the Arago II device, a light curing unit. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "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..."

This means the device was cleared based on a demonstration of substantial equivalence to a previously legally marketed predicate device, not on meeting specific performance acceptance criteria via a new study. The 510(k) process typically involves showing that a new device is as safe and effective as a predicate through various comparisons, which may include performance data, but it does not necessarily require a separate, new clinical study with pre-defined acceptance criteria if substantial equivalence can be demonstrated through other means (e.g., comparison of technical characteristics, non-clinical tests).

Therefore, I cannot provide the requested information from the provided 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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 6 1997

Ms. Lisa Moiica Documentation Control Coordinator Premier Laser Systems, Inc. 3 Morgan Irvine, California 92618

Re: K971118 Trade Name: Arago II Regulatory Class: II Product Code: GEX Dated: September 11, 1997 Received: September 17, 1997

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 requirements , 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}------------------------------------------------

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.

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,

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}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

    1. Curing of all light cured bonding materials.
    1. Curing of pit and fissure sealants (unfilled resins).
    1. Curing for all classes of composite restorations (filled resins).
    1. Curing for endodontic composite cores.
  • న. Curing composite cements for porcelain facings and inlays.
  • Q. Curing of light activated periodontal splint material.
    1. Curing of light activated prosthetic reline and repair material.
    1. Curing used in the fabrication of laboratory indirect light activated restorations and provisional restorations.
  • ರು. Illumination purposes for the adjunctive use in caries detection.
    1. Illumination purposes for the adjunctive use for endodontic orifice location.
    1. Light activation for bleaching materials for teeth whitening.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Or

e Evaluation (ODE)

Division Sign-Off)

(Division Sign-Off) (Division of General Restorative Devices (4711) (1) { })
510(k) Number _______________________________________________________________________________________________________

Prescription Use✓
(Per 21 CFR 801.109)

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.