EZLASE

K061898 · Biolase Technology, Inc. · GEX · Jan 26, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K061898
• Device Name: EZLASE
• Applicant: Biolase Technology, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty Laser Periodontal procedures, including: Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

Device Story

EZLase is a dental diode laser system used by clinicians for soft tissue procedures. It utilizes GaAlAs and/or InGaAsP solid-state laser diodes to emit infrared energy, transmitted via flexible fiberoptic cable to a handpiece. A visible light beam assists in pinpointing the treatment site. The device allows adjustment of power output and pulse width. It functions by incising, excising, vaporizing, coagulating, and ablating intra-oral soft tissues. The system is intended for use in a dental clinic setting. By providing precise tissue management, it benefits patients through controlled surgical intervention and periodontal therapy, potentially improving clinical indices like probe depth and gingival health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance specifications compared to predicate devices.

Technological Characteristics

Solid-state laser diode (GaAlAs and/or InGaAsP); infrared energy emission; flexible fiberoptic cable delivery; adjustable power and pulse width; visible aiming beam; Class II surgical laser instrument.

Indications for Use

Indicated for patients requiring oral soft tissue surgery, including biopsies, frenectomy, gingivectomy, implant recovery, and periodontal procedures like sulcular debridement. Contraindicated for patients with conditions complicating local procedures, such as bleeding disorders, immune deficiencies, or specific heart/lung diseases; medical clearance advised for high-risk 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

• LaserSmile (K030539)
• LVI Lase (K041721)
• DioDent II (K050274)

Submission Summary (Full Text)

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| Regulatory<br>Authority: | Safe Medical Devices Act of 1990,<br>21 CFR 807.92 | K061898 | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------|--------|------|
| Company: | BioLase Technology, Inc.<br>4 Cromwell<br>Irvine, CA 92618 | | JAN 26 | 2007 |
| Contact: | Ms. Ioana M. Rizoiu<br>BioLase Technology, Inc.<br>4 Cromwell<br>Irvine, CA 92618<br>Tel: [phone] Fax: [phone] | | | |
| Trade Name: | <i>EZLase</i> TM | | | |
| Common Name: | Dental diode laser | | | |
| Classification Name: | Surgical laser instrument | | | |
| Classification Code: | 79 GEX | | | |
| Equivalent Devices: | | LaserSmileTM | | |
| BioLase Technology, Inc. | | | | |
| Hoya ConBio, Inc. | | LVI lase | | |
| Hoya ConBio, Inc. | | DioDent II | | |

# 510(k) Summary of Safety and Effectiveness Information

## Device Description:

The EZLase™ dental diode laser system may be used to perform various soft tissue dental applications. The system uses advanced laser technology to incise, excise, vaporize, coagulate and ablate intra-oral soft tissues. A Gallium Aluminum Arsenide (GaAlAs) and/or an Indium Gallium Arsenide Phosphorous solid-state laser diode emit infrared laser energy to the various oral soft tissues targeted during procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.

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# K061898

## Indications for Use:

## Dental Soft Tissue Indications for:

Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty

### Laser Periodontal procedures, including:

Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket

Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

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# 15061898

# Contraindications:

- 6.6.1 All clinical procedures performed with EZLase™ must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea, an immune system deficiency and other such conditions. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.
# Substantial Equivalence:

There are no unique applications, indications, materials or specifications presented herein. All the submitted indications for use retain the same meaning as their equivalent indications cleared by the FDA in the following 510k clearances: K030539 for LaserSmile™, K041721 for LVI Lase and K050274 for DioDent II.

## Conclusion:

EZLase™ is substantially equivalent to dental products previously cleared for marketing. EZLase™ performs the same indications for use through the same mechanism as the other cleared devices. Evidence of equivalence has been demonstrated through the following:

- . Equivalent performance specification
- . Equivalent intended use
- Feature comparison table

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biolase Technology Inc. % Ms. Ioana M. Rizoiu VP. Clinical Research and Development 4 Cromwell Irvine, California 92618

JAN 2 6 2007

Re: K061898 Trade/Device Name: EZLase™ 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: December 19, 2006 Received: December 20, 2006

Dear Ms. Rizoiu:

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. Ioana M. Rizoiu

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/industry/support/index.html.

Sincerely yours.

Hyatt Rhoden

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

Enclosure

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#### 510(k) Number (if known): K061898

EZLase™M Device Name:

### Indications for Use:

#### Dental Soft Tissue Indications for:

Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty

#### Laser Periodontal procedures, including:

Laser soft tissue curettage Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket

Stupt Rhodes for MXM
Division Sign-Off

Division of General, Restorative and Neurological Devices

(k) Number K 06 1898

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Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

Stephen Rhodes for mxm
(Mission Sign-Off)

Wision of General, Restorative nd Neurological Devices

Number KOC 1898