LASERSMILE

K030539 · Biolase Technology, Inc. · GEX · Oct 10, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030539
• Device Name: LASERSMILE
• Applicant: Biolase Technology, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dental Soft Tissue Indications for: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: 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 Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium 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.) Tooth Whitening Indications: Laser assisted whitening/bleaching of teeth. Light activation for bleaching materials for teeth whitening.

Device Story

LaserSmile is a dental diode laser system using a Gallium Aluminum Arsenide (GaAlAs) solid-state laser diode to generate optical energy. The device is operated by dental professionals in a clinical setting. Laser energy is delivered via a flexible fiberoptic handpiece; a visible light beam at the distal end assists in targeting the treatment area. The system allows for adjustment of optical power output and pulse settings. For soft tissue applications, the laser performs incision, excision, vaporization, ablation, and coagulation. For tooth whitening, the laser provides light activation for bleaching materials. The device enables precise soft tissue management and periodontal debridement, potentially reducing patient discomfort and improving clinical indices compared to traditional methods. Clinicians use the device based on patient medical history and clinical judgment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, intended use, and performance specifications compared to predicate devices.

Technological Characteristics

Gallium Aluminum Arsenide (GaAlAs) solid-state laser diode; flexible fiberoptic handpiece delivery system; adjustable optical power and pulse settings; visible aiming beam; standalone dental surgical instrument.

Indications for Use

Indicated for dental patients requiring soft tissue surgery (incision, excision, ablation, coagulation), periodontal procedures (curettage, sulcular debridement), or tooth whitening. Contraindicated in patients with periodontal disease, exposed root surfaces, or damaged/fissured enamel for whitening procedures. Clinicians must exercise caution for patients with local anesthetic allergies, heart/lung disease, bleeding disorders, sleep apnea, or immune deficiencies.

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

• TwiliteTM (K991994)
• Waterlase® (K011041)

Submission Summary (Full Text)

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OCT 1 0 2003

030539

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# 510(k) Summary of Safety and Effectiveness Information

| Regulatory<br>Authority: | Safe Medical Devices Act of 1990,<br>21 CFR 807.92 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | BioLase Technology, Inc.<br>981 Calle Amanecer<br>San Clemente, CA 92673 |
| Contact: | Ms. Ioana M. Rizoiu<br>BioLase Technology, Inc.<br>981 Calle Amanecer<br>San Clemente, CA 92673<br>[phone] [phone] Fax |
| Trade Name: | LaserSmileTM |
| Common Name: | Dental diode laser |
| Classification Name: | Surgical laser instrument |
| Classification Code: | 79 GEX |
| Equivalent Devices: | |
| | BioLase Technology, Inc. Waterlase® |
| | BioLase Technology, Inc. TwiliteTM |

# Device Description:

The LaserSmile™ dental diode laser system may be used to perform several dental applications. LaserSmile™ uses advanced laser technology to incise, excise and ablate intraoral soft tissues and to activate a bleaching material for whitening/bleaching teeth safely and effectively. A Gallium Aluminum Arsenide (GaAlAs) solid state laser diode provides optical energy to oral soft tissues and tooth bleaching compounds.

A flexible fiberoptic handpiece delivers the LaserSmile™ laser energy. A visible light emitted from the handpicce distal end pinpoints the area of treatment. The optical power output and pulse may be adjusted to specific user requirements.

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## Indications for Use:

## Dental Soft Tissue Indications for:

Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

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 Leukoplakja 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 ulccrs 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 Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium 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.)

# Tooth Whitening Indications:

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

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030539 7/3

#### Contraindications:

All clinical procedures performed with LaserSmile™ 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 or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.

Patients with periodontal disease and/or exposed root surfaces are not candidates for laser tooth bleaching/whitening. Also, patients with damaged or fissured enamel are not candidates for laser bleaching/whitening.

#### 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 K991994 (Twilite™, original indications for use), and in K011041 (Waterlase®, expanded indications for use).

#### Conclusion:

LaserSmile™ is substantially equivalent to dental products previously cleared for marketing. LaserSmile™ 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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

# OCT 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ioana M. Rizoiu Vice President, Clinical Research and Development BioLase Technology, Inc. 981 Calle Amanecer San Clemente, CA 92673

Re: K030539

Trade/Device Name: LaserSmile™ Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: July 11, 2003 Received: July 16, 2003

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 (OS) 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. Daryl Wisdahl

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,

Miriam C. Provost

feCelia 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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#### 510(k) Number (if known): K030539

LaserSmile™ Device Name:

Indications for Use:

Dental Soft Tissue Indications for:

Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

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 coaqulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of qinqival 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 Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

Muriam C. Provost

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

510(k) Number K630539

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# Tooth whitening procedures, including:

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use (Per 21 CFR 801.109) | |
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or

| Over-The-Counter-Use | |
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| | Miriam C. Provost |
|--|-----------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative and Neurological Devices |

| 510(k) Number | K030539 |
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