PERIOLASE ND:YAG DENTAL LASER SYSTEM

K030290 · Millennium Dental Technologies, Inc. · GEX · Jul 26, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K030290
• Device Name: PERIOLASE ND:YAG DENTAL LASER SYSTEM
• Applicant: Millennium Dental Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber optic delivery system. The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following is the additional oral-pharngeal indication for use for which the device will be marketed: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal re- treatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingivaltooth mobility tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new- attachment to the root surface in the absence of long junctional epithelium.)

Device Story

PerioLase is a pulsed Nd:YAG laser (1064nm) for soft tissue surgery. System comprises a cabinet housing laser head, power supply, cooling system, and microprocessor control panel, connected to a fiber optic delivery system. Operated by clinicians in dental/surgical settings. Laser energy is delivered via contact fiber optic to perform ablation, incision, excision, vaporization, and coagulation of soft tissues. Clinical benefit includes precise tissue management and periodontal pocket debridement. Output is controlled by the clinician via the control panel to adjust pulse durations (100-650µsec).

Clinical Evidence

Clinical evidence consists of human histological and radiographic data from a controlled prospective university-based clinical study supporting the laser-assisted new attachment procedure (LANAP) claim.

Technological Characteristics

Nd:YAG laser; 1064nm wavelength; variable pulse durations (100-650µsec). System includes laser head, power supply, cooling system, and microprocessor control panel. Fiber optic delivery system. Class II device.

Indications for Use

Indicated for patients requiring intraoral soft tissue dental, oral maxillo-facial, and cosmetic surgery, including procedures like gingivectomy, frenectomy, lesion removal, and sulcular debridement. Also indicated for laser-assisted new attachment procedures (LANAP) and various general surgical applications across multiple medical specialties.

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

• PerioLase Dental Laser (K030290)

Submission Summary (Full Text)

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This 510(K) Summary of safety and effectiveness for the Millennium Dental Technologies PerioLase Dental Laser This 310(K) Submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Millennium Dental Technologies, Inc. |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 10945 South Street, Suite 104-A<br>Cerritos, CA 90703 |
| Contact Person: | David M. Harris, Ph.D. |
| Telephone: | [phone] - Phone<br>[phone] - FAX |
| Preparation Date: | January 01, 2003 |
| Device Trade Name: | PerioLase Dental Laser |
| Common Name: | Nd:YAG Pulsed Laser |
| Classification Name: | Instrument, Surgical, Powered, Laser<br>79-GEX<br>21 CFR 878-48 |
| Legally Marketed Predicate<br>Device: | PerioLase Dental Laser |
| Description of the Millennium<br>Dental Technologies PerioLase<br>Dental Laser | The PerioLase is a FR Nd:YAG laser producing laser emission at<br>1064nm with variable pulse durations (100-650µsec). The laser<br>consists of two interconnected sections: The cabinet which houses<br>the laser head, the power supply, the cooling system and the<br>microprocessor with control panel; and the fiber optic delivery<br>system. |
| Clinical Performance Data: | The new clinical outcome claim is based on human histological and<br>radiographic data from a controlled prospective University-based<br>clinical study. |
| Summary Basis of Equivalence: | N/A |

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| Summary of Safety and Effectiveness Information PerioLase<br>Dental Laser System<br>Premarket Notification, Section 510(k) | MILLENNIUM DENTAL<br>TECHNOLOGIES, INC.<br><br>JANUARY 17, 2003 |
|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use: | The following are the oral-pharngeal indications for use<br>for which the device will be marketed:<br>Abscess Incision and Drainage<br>Apthous Ulcers Treatment<br>Biopsies Excision and Incision<br>Crown lengthening<br>Hemostatic assistance<br>Fibroma Removal<br>Frenectomy<br>Frenotomy<br>Gingival Incision and Excision<br>Gingivectomy<br>Gingivoplasty<br>Operculectomy<br>Oral Papillectomy<br>Tissue retraction for Impression<br>Vestibuloplasty.<br>Selective ablation of enamel (first degree) caries<br>Exposure of unerupted / partially erupted teeth<br>Implant recovery<br>Lesion (tumor) removal<br>Leukoplakia<br>Pulpotomy<br>Pulpotomy as adjunct to root canal therapy<br>Removal of filling material such as gutta percha or<br>resin as adjunct treatment during root canal re-<br>treatment<br>Sulcular debridement (removal of diseased or inflamed<br>soft tissue in the periodontal pocket) to improve<br>clinical indices including gingival index, gingivaltooth mobility tooth mobility. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 6 2004

Millenium Dental Technologies, Inc. c/o David M. Harris, Ph.D. Bio-Medical Consultants, Inc. 4256 Heyer Avenue Castro Valley, California 94546

Re: K030290

Trade/Device Name: PerioLase Nd:YAG Dental Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 21, 2004 Received: April 27, 2004

Dear Dr. Harris:

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 your 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.

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 rooduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - David M. Harris, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you'ls begal 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), 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 your responsibilities under the Act 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,

Mark A. Melkersen

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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## Indications for Use

## 510(k) Number : K030290

## PerioLase Nd:YAG Dental Laser System Device Name(s):

## indications For Use:

The PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber optic delivery The device will be used in the following areas: general and cosmetic dentistry system. otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following is the additional oral-pharngeal indication for use for which the device will be marketed:

- Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-. attachment to the root surface in the absence of long junctional epithelium.)
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milkerson

I, Restorative. and Neurological Devices

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510(k) Number K030290