VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM

K070296 · Ace Vision Group · GEX · Oct 3, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070296
• Device Name: VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM
• Applicant: Ace Vision Group
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VisioLite® is indicated for the ophthalmic soft tissue surrounding the eye and orbit.

Device Story

VisioLite® Ophthalmic Er:YAG Laser System generates 2940nm wavelength laser beam; high water/collagen/hydroxyapatite absorption enables rapid, precise vaporization and ablation of soft tissues surrounding eye and orbit. Device operates in pulsed mode (pulse width < 300 μsec) with energy output up to 350 mJ. Used by clinicians for ophthalmic soft tissue procedures. Precise tissue removal minimizes collateral thermal damage. System design is equivalent to predicate Er:YAG laser systems.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety, laser safety, and electromagnetic compatibility testing.

Technological Characteristics

Er:YAG laser; 2940 nm wavelength; pulsed operation (< 300 μsec pulse width); up to 350 mJ energy output; 230 mrad beam divergence at tip; Class IV laser product.

Indications for Use

Indicated for ophthalmic soft tissue surrounding the eye and orbit.

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

• Oculase MD (K052354)
• Laserscope Vela Erbium:YAG laser system (K971843)

Reference Devices

• Delight laser System from Hoya ConBio

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for ACE VISION. The logo consists of an eye-like shape with a six-pointed star in the center. Below the eye is the text "ACEVISION" in a bold, sans-serif font. The logo is simple and modern, and the use of the eye shape suggests that the company is involved in vision care or a related field.

OCT 3 ี 2007

510(k) Summary (per 21 CFR 807.92)

K070296

Applicant I. ACE VISION GROUP 247 N. Westmonte Road Altamonte Springs, FL 32714

> Tim Elliott, VP Operations Contact Person: Tel: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: August 17, 2007

### II. Device Name

| Proprietary Name: | VisioLite® Ophthalmic Er:YAG Laser System |
|-----------------------|----------------------------------------------------------------------------------------|
| Common/ Usual Name: | Laser instrument, surgical, powered |
| Classification Name: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology |
| Regulation Number: | 878.4810 |
| Product Codes: | GEX |
| Classification: | 2 |
| Classification Panel: | General & Plastic Surgery |

## III. Predicate Device

The VisioLite® Ophthalmic Er: YAG Laser System is substantially equivalent to the Oculase MD from Biolase Technology Inc and the Laserscope Vela Erbium: YAG laser system. The Oculase MD was cleared by the FDA under 510(k) K052354 and the Vela Erbium:YAG laser system was cleared by the FDA under 510(k) K971843

## IV. Intended Use of the Device

The VisioLite® is indicated for the ophthalmic soft tissue surrounding the eye and orbit.

#### V. Description of the Device

The VisioLite® Ophthalmic Er: Y AG Laser System creates a laser beam with a wavelength of 2940nm, which is highly absorbed by water, collagen and hydroxy apatite and therefore causes rapid vaporization, or ablation, in both hard and soft biological tissues. Because the absorption is highly efficient, tissue removal is very precise with virtually no collateral thermal damage.

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Image /page/1/Picture/0 description: The image shows the logo for ACE VISION. The logo consists of an eye-shaped symbol with a six-pointed star in the center. Below the symbol is the text "ACE VISION" in a bold, sans-serif font. Underneath "ACE VISION" are the words "REAL COMPANY. REAL PEOPLE."

The VisioLite® Ophthalmic Er:YAG Laser System is equivalent in design to the Delight laser System from Hoya ConBio.

#### VI. Summary of the Technical Characteristics

| Type of Laser | Er:YAG |
|---------------------------------------|------------------------------------------|
| Laser Beam Wavelength | 2940 nm (invisible, mid-infrared) |
| Energy Output | Up to 350 mJ |
| Type of Operation | Pulsed Only, Pulse Width < 300 $\mu$ sec |
| Angle of Laser Beam Divergence at Tip | 230 mrad |
| Class of Laser Products | Class IV |

#### VII. Safety & Effectiveness

There are no substantial differences between the VisioLite® Ophthalmic Er: Y AG Laser System defined in this 510(k) submission and the predicate devices.

The VisioLite® Ophthalmic Er:YAG Laser System included electrical safety testing , laser safety testing and electromagnetic compatibility testing.

The VisioLite® Ophthalmic Er:YAG Laser System meets the applicable requirements of CFR 1040.

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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 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 logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ace Vision Group % Emergo Group Inc. Mr. Ian P. Gordon Senior Vice President 1705 South Capital of Texas Highway Suite 500 Austin, Texas 78746

OCT 3 2007

Re: K070296

Trade/Device Name: VisioLite® Ophthalmic Dr: YAG 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: September 18, 2007 Received: September 19, 2007

Dear Mr. Gordon:

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

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Page 2 - Mr. Ian P. Gordon

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 obtains 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 20tm1

Sincerely yours,

for

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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Image /page/4/Picture/0 description: The image shows the logo for ACEVISION. The logo consists of an eye-shaped symbol with a six-pointed star in the center. Below the eye symbol, the word "ACEVISION" is written in a bold, sans-serif font. Underneath the company name is the text "ONE COMPANY ONE VISION" in a smaller font.

# 4. Indication for Use Statement

510(k) Number (if known): K070296

Device Name: VisioLite® Ophthalmic Er:YAG Laser System

Indications for Use:

The VisioLite® is indicated for the ophthalmic soft tissue surrounding the eye and orbit.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number k070296