DIODENT DENTAL LASER SYSTEM

K022351 · Continuum Electro-Optics, Inc. · GEX · Oct 16, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022351
• Device Name: DIODENT DENTAL LASER SYSTEM
• Applicant: Continuum Electro-Optics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Light activation for bleaching materials for teeth whitening. Laser-assisted bleaching/whitening for teeth.

Device Story

DioDent Dental Laser System is a medical laser used for teeth whitening. Device functions via light activation of bleaching materials applied to teeth. Operated by dental professionals in a clinical setting. Laser energy facilitates the bleaching process. Output is laser light directed at the patient's teeth to accelerate whitening agents. Benefits include professional-grade teeth whitening.

Clinical Evidence

No clinical data.

Technological Characteristics

Medical laser system for surgical/dental applications. Class II device (Product Code GEX). Operates as a laser surgical instrument.

Indications for Use

Indicated for light activation of bleaching materials for teeth whitening and laser-assisted teeth whitening.

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.

Predicate Devices

• TwiLite/TwiLiteWhite (Biolase Technology, Inc.)
• Ceralas Model D15 (Ceramoptec, Inc.)
• Opus 10 (OpusDent, Inc.)

Submission Summary (Full Text)

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510(k) Summary

| K022351 | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Continuum Electro-Optics, Inc.<br>3150 Central Expressway<br>Santa Clara, CA 95051<br>[phone] - Phone<br>[phone] - FAX |
| Contact: | Thomas J. Haney<br>Manager, Dental Products |
| Date Summary Prepared: | July 17, 2002 |
| Device Trade Name: | DioDent Dental Laser System |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, Surgical, Powered, Laser |
| Equivalent Device(s): | TwiLite/TwiLiteWhite<br>by Biolase Technology, Inc.<br>Ceralas Model D15<br>by Ceramoptec, Inc.<br>Opus 10<br>by OpusDent, Inc. |
| Intended Use: | Teeth Whitening |
| Comparison: | Principles of operation, function and<br>intended use for the DioDent,<br>TwiLite/TwiLiteWhite, Ceralas Model D15<br>and Opus 10 laser systems are identical. |
| Non-Clinical Performance Data: | None. |
| Clinical Performance Data: | None. |
| Additional Information: | None. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

## OCT 1 6 2002

Continuum Electro-Optics, Inc. Thomas J. Haney Manager, Dental Products 3150 Central Expressway Santa Clara, California 95051

Re: K022351

Trade/Device Name: DioDent Dental Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: July 17, 2002 Received: July19, 2002

Dear Mr. Haney:

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. Iisting 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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.

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 setforth 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.

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Page 2 – Mr. Thomas J. Haney:

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 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 21 CFR Part 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 Part 807.97). Other general information on your 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,

Atyt Qurch
Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1.

2.

510(k) Number (if known): .

0223)1

Indications for Use:

.

Light activation for bleaching materials for teeth whitening. Laser-assisted bleaching/whitening for teeth.

(Do Not Write Below this Line. Continue on Another Page if Needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Styp Rhode

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number | C 022351

Perscription Use:
(Per 21 CFR 801.109)

✓

Over-The-Counter Use: (Optional Format 1-2-96)

CO0083