VIZILITE EYEWEAR

K080043 · Zila, Inc. · NXV · Apr 4, 2008 · Dental

Device Facts

• Record ID: K080043
• Device Name: VIZILITE EYEWEAR
• Applicant: Zila, Inc.
• Product Code: NXV · Dental
• Decision Date: Apr 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6350
• Device Class: Class 2

Intended Use

The ViziLite Eyewear is reusable and intended to be an optional accessory worn by health care professionals during chemiluminescent oral exam.

Device Story

ViziLite Eyewear is a reusable, polarized, filtered accessory worn by healthcare professionals during oral chemiluminescent examinations. It functions by filtering ambient light, allowing transmission of 430-580nm light, which enables clinicians to perform oral lesion identification and monitoring without requiring a darkened room. The device is used in conjunction with the ViziLite chemiluminescent light source and the TBlue Oral Lesion Marking System. By improving the visibility of oral mucosal changes—such as atypia, dysplasia, leukoplakia, erythroplakia, or occult lesions—the eyewear assists the clinician in identifying and marking lesions for further evaluation. The device does not alter the clinical behavior or decision-making process regarding the lesion; it serves as an aid to improve the efficiency and environment of the examination procedure.

Clinical Evidence

Clinical testing was performed to support the use of the ViziLite Eyewear. The testing demonstrated that the eyewear allows a trained healthcare professional to perform the ViziLite Plus with TBlue Oral Lesion Marking Procedure effectively without the need for a darkened room, maintaining the safety and efficacy of the examination.

Technological Characteristics

Reusable polarized filtered eyewear. Designed to transmit light in the 430-580nm range. Functions as an optical filter to reduce ambient light interference during chemiluminescent oral examinations.

Indications for Use

Indicated for use by health care professionals as polarized filtered eyewear to reduce ambient light effects during chemiluminescent oral examinations when a darkened room is unavailable. Designed to transmit 430-580nm light. Used in conjunction with the ViziLite Plus with TBlue Oral Lesion Marking Procedure for patients at increased risk for oral cancer.

Regulatory Classification

Identification

An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.

Predicate Devices

• ViziLite Blue Oral Exam Product

Submission Summary (Full Text)

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K080043

172

#### SECTION 12 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS APR - 4 2008

## K080043 ViziLite Eyewear

Submitter's Name: Gary Klinefelter

Address: 5227 North 7th Street

Phoenix, AZ 85014-2800

Phone: [phone]

Fax: [phone]

Consultant: Suzanne Parisian, M.D.

MD Assist, Inc.

Device Name: ViziLite Eyewear

Common Name: Oral Examination Light

Classification Name: Operating Light, Dental

Substantial Equivalence: ViziLite Blue Oral Exam Product

#### 1. INTENDED USE:

The ViziLite Eyewear is reusable and intended to be an optional accessory worn by health care professionals during chemiluminescent oral exam.

#### INDICATIONS FOR USE: INDICATIONS FOR USE:

The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.

### Instructions for Use "VIZILITE EYEWEAR"

The reusable ViziLite eyewear, as supported by clinical testing, allows a trained health care professional the option to use the evewear throughout the ViziLite Plus with TBlue Oral Lesion Marking Procedure for oral chemiluminescent examination without the need for darkening a room and without altering safety and efficacy.

Date of Submission: March 24, 2008

Contact: Mark Bride, DDS

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K080043

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Following a conventional oral exam with ambient light, the trained health care professional can put on the ViziLite Eyewear for the ViziLite Plus with TBlue Oral Lesion Marking Procedure to improve oral mucosal lesion identification, evaluation and monitoring in patients at increased risk for oral cancer. The "ViziLite" is the system's chemiluminescent light source used for identification and evaluation of oral mucosal changes which can include atypia, dysplasia, leukoplakia, erythroplakia, genetic change or occult lesions.

While still wearing the ViziLite Eyewear, oral lesions identified by ViziLite can be marked using the TBlue Oral Lesion Identification and Marking System to help preserve the anatomic characteristics. The marking dye, when positive, acts as a lesion marker allowing removal of the ViziLite while preserving the anatomic characteristics of the lesion. Whether a lesion marks with dye or not should not alter the clinician's clinical behavior as dictated by the results of the ViziLite examination.

The ViziLite Eyewear can be worn throughout the ViziLite and TBlue Oral Lesion Marking procedure without interfering with the examination.

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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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 4 2008

Mark Bride, DDS Vice President, Medical Affairs Zila, Incorporated 5227 North 7th Street Phoenix, Arizona 85014-2800

Re: K080043

Trade/Device Name: VIZILITE EYEWEAR Regulation Number: 872.6350 Regulation Name: Dental Operating Light Regulatory Class: II Product Code: NXV Dated: March 25, 2008 Received: March 27, 2008

Dear Dr. Bride:

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.

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Page 2 - Dr. Bride

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.

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,

Suitt. Y. Mckinzie Ovid.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 1- INDICATIONS FOR USE

K080043

510(k) Number: K080043

Device Name: VIZILITE EYEWEAR

INDICATIONS FOR USE: The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------------------------------|
| Prescription Use | X |
| (Per 21 CFR 801.109) | |
| OR | Over-The-Counter Use ___________ |
| | (Optional Format 1-2-96) |

*Signature*
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control & Dental Devices

| 510(k) Number | K080043 |
|---------------|---------|
|---------------|---------|