VISULAS TRION

K072514 · Carl Zeiss Meditec, AG · GEX · Sep 21, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072514
• Device Name: VISULAS TRION
• Applicant: Carl Zeiss Meditec, AG
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The VISULAS Trion is intended for use in photocoagulating ocular tissues for the treatment of diseases of the eye, such as: Photocoagulation of the retina . Trabeculoplasty for treatment of glaucoma . Iridotomy for treatment of glaucoma. The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.

Device Story

Diode-pumped, solid-state, three-color laser system (green, yellow, red); delivers laser energy for ocular photocoagulation. Components: laser console, detachable operating control panel, two fiber ports, foot switch. Delivery via transpupillary (slit lamp, indirect ophthalmoscope) or intraocular endoprobes. Operated by clinicians in clinical settings. Output: controlled laser radiation for tissue treatment. Clinical benefit: therapeutic management of retinal diseases and glaucoma.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Diode-pumped, solid-state laser; three-color output (green, yellow, red). Includes laser console, control panel, fiber ports, and foot switch. Delivery via transpupillary or intraocular endoprobes. Class II device.

Indications for Use

Indicated for patients requiring ocular tissue photocoagulation for retinal diseases, glaucoma-related trabeculoplasty, or iridotomy.

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

• VISULAS 532s (K013402)
• Novus® Varia™ Ophthalmic Laser and Delivery Devices (K022181)
• Multi Color Laser Photocoagulator Model MC-300 (K042785)

Submission Summary (Full Text)

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# 510(K) SUMMARY

## 5. 510 (K) SUMMARY

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510 (k) SUMMARY (per 21 CFR §807.92)

## VISULAS Trion

# GENERAL INFORMATION

| Name and Address of the<br>Applicant: | Carl Zeiss Meditec AG<br>Goeschwitzer Strasse 51-52<br>07745 Jena, Germany<br>Est. Reg. No. 9615030 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Kent W. Jones<br>Vice President, RA/CA/QA/Compliance<br>Carl Zeiss Meditec Inc.<br>5160 Hacienda Drive<br>Dublin, California 94568<br>[phone] (phone)<br>[phone] (fax) |
| Classification name: | Laser Instrument, Surgical, Powered |
| Classification: | Class II (acc. 21 CFR 878.4810) |
| Product Code: | GEX |
| Trade/Proprietary name: | VISULAS Trion |
| PREDICATE DEVICE | |
| Company:<br>Device: | Carl Zeiss Meditec AG<br>VISULAS 532s (K013402) |
| Company:<br>Device: | Lumenis<br>Novus® Varia™ Ophthalmic Laser and Delivery Devices<br>(K022181) |
| Company:<br>Device: | Nidek<br>Multi Color Laser Photocoagulator Model MC-300<br>(K042785) |

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## INTENDED USE

The VISULAS Trion is intended for use in photocoagulating ocular tissues for the treatment of diseases of the eye, such as:

- Photocoagulation of the retina .
- Trabeculoplasty for treatment of glaucoma .
- . Iridotomy for treatment of glaucoma.

The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.

### DEVICE DESCRIPTION

The VISULAS Trion is a diode-pumped, solid state, three-color laser system for green, yellow and red wavelengths, based upon the predicate VISULAS 532s (K013402). The VISULAS Trion laser system consists of the following components: Laser console as the source of laser radiation with detachable operating control panel, two fiber ports for application devices and a foot switch. Application devices for laser radiation delivery are offered via either transpupillary or intraocular delivery, laser slit lamp, laser indirect ophthalmoscope and endoprobes.

# SUBSTANTIAL EQUIVALENCE

The VISULAS Trion is substantially equivalent to the predicate devices identified previously. The VISULAS Trion is substantially equivalent to the predicate devices with regard to intended use, operating principle, function, and materials.

Evaluation performed on the VISULAS Trion supports the indications for use statement and demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness.

#### SUMMARY

As described in this 510(k) Summary, all testing deemed necessary was conducted on the VISULAS Trion to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### SEP 2 1 2007

Carl Zeiss Meditec AG % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street Buffalo, MN 55313

Re: K072514 Trade/Device Name: VISULAS Trion 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 6, 2007 Received: September 7, 2007

Dear Mr. Job:

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

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Page 2 - Mr. Mark Job

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

PdOL
Mark N. Melkerson

Dr.
12-11-2

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

Enclosure

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#### 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VISULAS Trion

The VISULAS Trion is intended for use in photocoagulating Indications for Use: ocular tissues for the treatment of diseases of the eye, such as:

- Photocoagulation of the retina .
- Trabeculoplasty for treatment of glaucoma .
- Iridotomy for treatment of glaucoma. .

The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------------------------------|---------|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | L072514 |

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