ARAGO

K971118 · Premier Laser Systems, Inc. · GEX · Dec 16, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971118
• Device Name: ARAGO
• Applicant: Premier Laser Systems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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 Story

Arago II is a dental light-curing and illumination device. It emits light to polymerize light-activated dental materials, including bonding agents, composites, sealants, and prosthetic repair resins. Additionally, it provides illumination for clinical tasks such as caries detection, locating endodontic orifices, and activating tooth-whitening agents. Operated by dental professionals in clinical or laboratory settings. The device provides a light source that facilitates restorative, endodontic, and cosmetic dental procedures. By enabling rapid curing and improved visualization, it assists clinicians in performing dental restorations and treatments efficiently.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental light-curing unit; utilizes light energy for polymerization and illumination. Form factor designed for clinical/laboratory dental use. No specific materials, software, or connectivity details provided.

Indications for Use

Indicated for dental professionals requiring a light source for curing light-activated dental materials (bonding, sealants, composites, cements, splints, reline/repair materials) and for adjunctive illumination during caries detection, endodontic orifice location, and tooth 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}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

DEC 6 1997

Ms. Lisa Mojica
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 (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.

{1}

Page 2 - Ms. Lisa Mojica

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 [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,


Enclosure

{2}

Page 1 of 1

510(k) Number (if known): K971118

Device Name: AragoII

Indications For 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑
(Per 21 CFR 801.109)

Or

Over-The-Counter Use