DIOLASE 980 D LASER SYSTEM

K023547 · American Dental Technologies, Inc. · GEX · Apr 15, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023547
• Device Name: DIOLASE 980 D LASER SYSTEM
• Applicant: American Dental Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diolase 980 D Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.

Device Story

Portable diode laser system for intraoral/extraoral soft tissue surgery; ablates, incises, excises, and coagulates tissue. Uses contact fiber optic delivery system. Operator (dentist) selects pulsed or continuous operating modes via control interface. Laser wavelength 980 nm; output power up to 15W. Includes 635 nm red aiming beam. Air-cooled. Used in dental clinic settings. Provides precise tissue management; facilitates procedures like frenectomy, gingivectomy, and pulpotomy; aids in hemostasis and tissue retraction. Clinical benefit includes reduced bleeding and efficient soft tissue handling during dental procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to predicate device.

Technological Characteristics

Diode laser; 980 nm wavelength; 15W max output power; 635 nm red aiming beam; air-cooled; pulsed or continuous operating modes; contact fiber optic delivery; 110/220V power requirement; portable form factor (14" x 9" x 3").

Indications for Use

Indicated for intraoral and extraoral soft tissue procedures including gingival and epithelial lining applications in patients requiring surgical intervention, lesion excision, or dental soft tissue management.

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

• BioLitec Smilepro 980 nm Diode Laser

Submission Summary (Full Text)

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## K 023 547 510(k) Summary for DioLase 980 D Diode Laser System

#### 1. SPONSOR

American Dental Technologies, Inc. 555 Bear Lane Corpus Christi, TX 78405

Roger Dartt, CEO Contact Person: 1-800-320-1050 Telephone:

October 11, 2002 Date Prepared:

### 2. DEVICE NAME

DioLase 980 D Laser System Proprietary Name: Common/Usual Name: Dental Laser System Classification Name: Laser Surgical Instrument

### 3. PREDICATE DEVICES

BioLitec Smilepro 980 nm Diode Laser

#### 4. INTENDED USE

The Diolase 980 D Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.

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## 5. DEVICE DESCRIPTION

The Diolase 980 D Diode Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingival) using a contact fiber optic delivery system.

# 6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The Diolase 980 D Diode Dental Laser System has the same intended use and the same or substantially equivalent technical specifications and mechanism of action as compared with the named predicated devices. The comparison of specifications are as follows:

| Specifications | Biolitec Smilepro 980 | ADT Diolase 980 D |
|--------------------|-----------------------|----------------------|
| Wavelength | 980 nm | 980 nm |
| Output Power | 15W | 15W |
| Power Range | 1-15W | .2-15W |
| Increments | 1W | .2W - 1W |
| Operating Modes | Pulsed or Continuous | Pulsed or Continuous |
| Pulse Duration ON | .01 to 99.9 Sec. | .01 to 99.9 Sec. |
| Pulse Duration OFF | .01 to 99.9 Sec. | .01 to 99.9 Sec. |
| Aiming Beam | 635 nm; 4mW; Red | 635 nm; 4mW; Red |
| Cooling | Air Cooled | Air Cooled |
| Weight | 15 lbs. (9 kg) | 11 lbs. (5 kg) |
| Dimensions | 14" x 9" x 7" | 14" x 9" x 3" |
| Power Requirements | 110/220 V | 110/220 V |

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Image /page/2/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 image of an eagle with three heads, each head facing a different direction.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2003

Ms. Marcia Van Valen Regulatory Specialist American Dental Technologies, Inc. 12 Prairie Falcon Aliso Viejo, CA 92656

Re: K023547

Trade/Device Name: Diolase 980 D Diode 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: January 15, 2003 Received: January 16, 2003

Dear Ms. Van Valen:

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

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Page 2 - Ms. Marcia Van Valen

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), 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,

Muriam C. Provost

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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#### K 023547 510(K) Notification:

Device Name: Diolase 980 D Diode Dental Laser System

Indications for Use:

The following indications for use are the same as those approved on the predicate device. The DioLase 980 D Diode Dental Laser System is intended for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Diseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

K02354 510(k) Number -

Prescription Use (Per 21 CFR 801.109)

OR

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

American Dental Technologies, Inc. DioLase 980 D Diode Laser 510(k)