RMO PLASMA CURING LIGHT

K024374 · Lokki Lasers Medicaux · EBZ · Mar 10, 2003 · Dental

Device Facts

• Record ID: K024374
• Device Name: RMO PLASMA CURING LIGHT
• Applicant: Lokki Lasers Medicaux
• Product Code: EBZ · Dental
• Decision Date: Mar 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RMO Plasma Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Device Story

RMO Plasma Curing Light functions as high-intensity illumination source for dental applications. Device emits light energy to catalyze polymerization of dental restorative materials and activate tooth whitening agents. Operated by dental professionals in clinical settings. Output consists of controlled light spectrum directed at oral cavity. Benefits include efficient curing of composites and accelerated whitening treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Plasma-based light source for polymerization. Class II device under 21 CFR 872.6070 (Ultraviolet Light for Polymerization). Product code EBZ.

Indications for Use

Indicated for use in dentistry as an illumination source for curing dental restorative materials and tooth whitening procedures.

Regulatory Classification

Identification

An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized image of a human figure in profile, repeated three times to create a sense of depth or movement. The figure is abstract and appears to be part of a larger design, possibly representing a bird or other symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2003

Lokki Lasers Medicaux C/O Mr. Hillard W. Welch 344 Annabelle Point Road Centerville, Massachusetts 02632-2402

Re: K024374

Trade/Device Name: RMO Plasma Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Light for Polymerization Regulatory Class: II Product Codes: EBZ Dated: November 12, 2002 Received: December 31, 2002

Dear Mr. Welch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 -- Mr. Hillard W. Welch

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97) you may obtain. Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runoar

Susan Runner, DDS, MÁ Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

The RMO Plasma Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | MEB for MSR |
|----------------|-----------------------------------------------|
| | (Division Sign/Off) |
| | Division of Anesthesiology, General Hospital, |
| | Infection Control, Dental Devices, |
| 510(k) Number: | K024374 |

| Prescription Use<br>(Per 21 CFR 801.109) <span style="text-decoration: underline;">✓</span> | OR <span style="text-decoration: underline;"> </span> Over-The-Counter Use <span style="text-decoration: underline;"> </span> |
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