DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER

K992013 · Continuum Biomedical, Inc. · GEX · Sep 8, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992013
• Device Name: DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER
• Applicant: Continuum Biomedical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

For removal of caries and for cavity preparation in primary and secondary teeth.

Device Story

DeL2940/DeLite Dental Erbium Laser is a medical laser system used by dental professionals for caries removal and cavity preparation. The device consists of a power supply, water cooling system, and optical bench. It delivers laser energy via a fiber optic cable with a quartz contact tip. Operating at 10 pulses per second with a pulse energy of 1 Joule, the system produces an average power of 10 watts. The laser energy facilitates the removal of dental hard tissue. The device is intended for use in a clinical dental setting.

Clinical Evidence

Clinical evidence includes foreign data from four studies (245 human teeth: 18 extracted, 23 scheduled for extraction, 204 in vivo) and domestic IDE study data (94 pediatric and 121 adult subjects). Non-clinical evidence includes two bovine studies (22 teeth) and two canine studies (174 teeth), with one canine study directly comparing laser treatment to traditional drilling. All studies supported the safety and effectiveness of the Er:YAG laser for the indicated dental procedures.

Technological Characteristics

Erbium laser system; 10 watts average power; 10 pulses per second; 1 Joule pulse energy. Delivery via fiber optic with quartz contact tip. Includes power supply, water cooling system, and optical bench. Class II device (21 CFR 878.48).

Indications for Use

Indicated for removal of caries and cavity preparation in primary and secondary teeth for pediatric and adult patients.

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

• Centauri Er: YAG Dental Laser System (Premier Laser Systems, Inc.)

Submission Summary (Full Text)

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## k992013

## 510(k) Premarket Notification – Additional Information DeL2940 Dental Erbium Laser: Hard Tissue Disease Continuum Biomedical August 24, 1999

## 510(k) Summary

| Submitter: | Continuum Biomedical<br>A Medical Division of Continuum Electro-Optics, Inc.<br>6533 Sierra Lane<br>Dublin, CA 94568 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Laurie A. Ridener<br>Regulatory Affairs Officer |
| Date Summary<br>Prepared: | June 15, 1999 |
| Device Trade Name: | DeL2940 Dental Erbium Laser, DeLite Dental Erbium Laser |
| Common Name: | Medical laser system |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device: | Centauri Er: YAG Dental Laser System, Premier Laser Systems, Inc. |
| Device Description: | DeL2940 Dental Erbium Laser consists of three interconnected sections: the power supply,<br>the water cooling system and the optical bench. Delivery is via fiber optic with a quartz<br>contact tip. At 10 pulses per second an a pulse energy of 1 Joules, the average power from<br>the laser is 10 watts. |
| Intended Use: | For removal of caries and for cavity preparation in primary and secondary teeth. |
| Comparison: | The DeL2940 Dental Erbium Laser is substantially equivalent to the Centauri Er: Y AG Dental<br>Laser System (Premier). |
| Nonclinical<br>Performance Data: | Data was provided on two bovine studies (22 teeth) and two canine studies (174 teeth). One<br>of the canine studies compared the laser treatment to the drill. All studies supported the<br>safety and effectiveness of the Er: Y AG laser for caries removal and cavity preparation. |
| Clinical Performance<br>Data: | Foreign data was provided from four clinical studies for a total of 245 human teeth (18<br>extracted, 23 scheduled for extraction and 204 in vivo). All studies supported the safety and<br>effectiveness of the Er.YAG laser for caries removal and cavity preparation. Domestic data<br>was provided from an IDE study for a total of 94 pediatric subjects and 121 adult subjects<br>treated with the DeL2940 Dental Erbium Laser. |
| Conclusion: | The DeL2940 Dental Erbium Laser is substantially equivalent to other currently marketed<br>erbium dental lasers for the removal of caries and for cavity preparation in primary and<br>secondary teeth. |
| Additional Information: | None requested at this time. |

PROPRIETARY DATA: This document and information contained herein may not be reproduced, used or disclosed without written permission of Continum Biomedical, A Medical Division of Continum Electro-Optics, Inc.,

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 8 1999

Ms. Liza A. Burns Regulatory Affairs Consultant Continuum Biomedical, Inc. 6533 Sierra Lane Dublin, California 94568

Re: K992013

Trade Name: DeL2940 Dental Erbium Laser, DeLite Dental Erbium Laser Regulatory Class: II Product Code: GEX Dated: June 15, 1999 Received: June 15, 1999

Dear Ms. Burns:

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 (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.

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Page 2 - Ms. Liza A. Burns

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 [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,

Sincerely, years,

Sallie M. Weaver, Ph.D., M.D.

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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| 510(k) Number (if known): | K992013 |
|---------------------------|----------------------------------------------------------------------------------|
| Device Name: | DeL2940 Dental Erbium Laser, DeLite Dental Erbium Laser |
| Indications for Use: | For Removal of Caries and for Cavity Preparation in Primary and Secondary Teeth. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K992013 |

| Prescription Use (Per 21 CFR 801.109) | <div>X</div> |
|---------------------------------------|--------------|
| OR Over-the-Counter Use | |

(Optional Format 1-2-96)
PROPRIETAR Y DATA: This document and information contained herein may not be reproduced, used or disclosed without written permission of Continual Biomedical. A Medical Division of Continuan Electro-Optics, Inc.