LVI AESTHETIC LASER

K041721 · Hoya Photonics, Inc. · GEX · Aug 5, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041721
• Device Name: LVI AESTHETIC LASER
• Applicant: Hoya Photonics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The LVI lase is intended for incision, excision, ablation, vaporization, and/or coagulation of oral soft tissue (including marginal and interdental gingival and epithelial lining of free gingiva). It is also intended for light activation for bleaching materials for teeth whitening, and laser-assisted bleaching/whitening for teeth whitening.

Device Story

LVI lase is a dental diode laser system used by dental professionals in clinical settings. It functions by delivering laser energy to oral soft tissues to perform surgical procedures including incision, excision, ablation, vaporization, and coagulation (hemostasis). Additionally, the device provides light energy for the activation of bleaching materials or direct laser-assisted teeth whitening. The clinician operates the device to target specific soft tissue areas or whitening agents, with the laser output facilitating precise tissue management or chemical activation for cosmetic whitening. The device benefits patients by providing a minimally invasive alternative to traditional surgical instruments for soft tissue management and an efficient method for dental whitening.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental diode laser system; operates as a surgical instrument for soft tissue management and light-activated teeth whitening. Technical specifications and materials are consistent with legally marketed diode laser surgical instruments. Energy source is a diode laser; device is intended for professional clinical use.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and hemostasis of oral soft tissue in patients requiring dental soft tissue procedures (e.g., biopsies, frenectomy, gingivectomy, implant recovery, pulpotomy, lesion removal) and for light-activated or laser-assisted teeth whitening.

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

• DioDent Dental Laser System by HOYA ConBio
• Aurora by Premier Laser System
• Twilite or Dentek LD-15 Diode Laser System by BioLase Technologies
• DioLase ST by American Medical Technology

Submission Summary (Full Text)

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AUG = 5 2004

K041721

## 9. 510(k) Summary

| Company: | HOYA ConBio (formerly Continuum Electro-Optics, Inc.)<br>47733 Fremont Blvd<br>Fremont, CA 94538<br>[phone] phone<br>[phone] fax |
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| Contact: | Jim Green<br>Vice President of Engineering |
| Device Trade Name: | LVI lase |
| Common Name: | Dental diode laser |
| Classification Name:<br>Classification Code: | Instrument, surgical, powered, laser<br>79-GEX |
| Equivalent Device(s): | DioDent Dental Laser System by HOYA ConBio,<br>Aurora by Premier Laser System,<br>Twilite or Dentek LD-15 Diode Laser System by BioLase<br>Technologies,<br>DioLase ST by American Medical Technology (formerly ADT) |
| Intended Use: | The LVI lase is intended for incision,<br>excision, ablation, vaporization, and/or coagulation of oral soft<br>tissue (including marginal and interdental gingival and epithelial<br>lining of free gingiva). It is also intended for light activation for<br>bleaching materials for teeth whitening, and laser-assisted<br>bleaching/whitening for teeth whitening. |
| Comparison: | The LVI lase, the DioDent Dental Laser<br>System, the Aurora Diode Laser System, the<br>Twilite/Dentek LD-15, the Dental Diode Laser, and the DioLase<br>ST are equivalent in operating parameters, physical characteristics,<br>and intended uses. (NOTE: Of the equivalent devices mentioned<br>here, only the DioDent and the Twilite are cleared for teeth<br>whitening intended uses. The LVI lase is seeking clearance for<br>this in this submission). |
| Nonclinical Performance<br>Data: | None |
| Clinical Performance Data: | None |
| Additional Information: | None |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

JUN 1 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HOYA ConBio, Inc. % Liza Burns and Associates Ms. Liza Burns Regulatory Consultant 19722 Westview Drive Twain Harte, California 95383

Re: K041721

Trade/Device Name: LVI lase Dental Diode Laser Regulation Number: 21 CFR 878.4800 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 21, 2004 Received: June 29, 2004

Dear Ms. Burns

This letter corrects our substantially equivalent letter of August 5, 2004.

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 (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 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

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Page 2 - Ms. Liza Burns

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.

This letter will allow you to continue 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,

Mark N. Melkers

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

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## 1. Indications for Use Statement

| 510(k) Number: | K041721 |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | LVI lase |
| Indications for Use: | For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.<br>Examples:<br>Excisional and incisional biopsies<br>Exposure of unerupted teeth<br>Fibroma removal<br>Frenectomy and frenotomy<br>Gingival troughing for crown impressions<br>Gingivectomy<br>Gingivoplasty<br>Gingival incision and excision<br>Hemostasis<br>Implant recovery<br>Incision and drainage of abscess<br>Leukoplakia<br>Operculectomy<br>Oral papillectomies<br>Pulpotomy<br>Pulpotomy as an adjunct to root canal therapy<br>Reduction of gingival hypertrophy<br>Soft tissue crown lengthening<br>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)<br>Treatment of aphthous ulcers<br>Vestibuloplasty<br>Biopsy incision and excision<br>Lesion (tumor) removal<br><br>For light activation for bleaching materials for teeth whitening<br>For laser-assisted bleaching/whitening for teeth. |
| (Division Sign-Off)<br>Division of General, Restorative,<br>and Neurological Devices<br>510(k) Number: | K041721 |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart D)

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OR

Over-the-Counter Use_ (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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