BQ/BM INTEGRATED LASER DELIVERY SYSTEM

K990665 · American Laser Corp. · HQF · May 17, 1999 · Ophthalmic

Device Facts

• Record ID: K990665
• Device Name: BQ/BM INTEGRATED LASER DELIVERY SYSTEM
• Applicant: American Laser Corp.
• Product Code: HQF · Ophthalmic
• Decision Date: May 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended as a laser delivery system for use by an opthalmologist in the treatment of ocular tissue.

Device Story

Device is a laser slit lamp adaptor; connects via fiber optic to a laser source and attaches to 900 BQ or 900 BM slit lamps. Directs and focuses laser energy on target ocular tissue parfocally with slit lamp image. Features include adjustable spot diameter (50-1000 microns), micromanipulator for spot positioning, and removable operator protective filter. Used by ophthalmologists in clinical settings to deliver therapeutic laser energy. Output is focused laser beam for treatment; enables precise targeting of ocular structures. Benefits include integration of therapeutic laser delivery with diagnostic slit lamp visualization.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design comparison to predicate devices.

Technological Characteristics

Laser delivery system for slit lamp attachment. Fiber optic transmission; adjustable focusing optics (50-1000 micron spot diameter); coaxial illumination with slit lamp; micromanipulator for spot positioning; integrated removable operator protective filter. Mechanical/optical design.

Indications for Use

Indicated for retinal photocoagulation and trabeculoplasty in patients requiring ocular tissue treatment by an ophthalmologist.

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Predicate Devices

• RO 5000 AR/FDY (K973220)
• Zeiss 130 SL Laser Slit Lamp

Submission Summary (Full Text)

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MAY 17 599

BQ/BM Integrated Laser Delivery System A.R.C. Laser Corporation March 1, 1999

K990665

### 510 (k) Summary

## Requlatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

# Company Name/Contact:

Daniel Hoefer A.R.C. Laser Corporation 1832 South 3850 West TEL [phone], FAX [phone]

Name of Device

BQ/BM Integrated Laser Delivery Trade Name: System

Laser Slit Lamp adaptor Common Name:

Laser Adaptor for Classification Name: Biomicroscope, slit lamp, AC powered.

86 HJQ Product Code:

#### Predicate Devices:

The BQ/BM Integrated Laser Delivery System is substantially equivalent to the following legally marketed devices: The RO 5000 AR/FDY (K973220) manufactured by G. Rodenstock Instrumente GmbH and the Zeiss 130 SL Laser Slit Lamp manufactured by Carl Zeiss.

#### Device Description:

When connected by fiber optic to a laser and properly attached to a 900 BQ or 900 BM slit lamp, the device directs and focuses laser energy on target tissue parfocally with the slit lamp image. An operator protective filter is incorporated into te device. The spot diameter is user adjustable, and the filter is removable to permit unimpaired viewing through the slit lamp microscope.

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BQ/BM Integrated Laser Delivery System A.R.C. Laser Corporation March 1, 1999

#### Intended Use:

The device is intended as a laser delivery system for use by an opthalmologist in the treatment of ocular tissue.

#### Technological Characteristics/Device Comparison:

The BO/BM Integrated Laser Delivery System is intended for attachment to slit lamps that are designed for use as diagnostic instruments, enabling them to be used in the delivery of therapeutic laser energy. Like the predicate devices, laser energy is transmitted through adjustable focusing optics, which allow the user to change the diameter of the laser spot from 50 to 1000 microns. As with the predicate devices, the laser energy is directed coaxially with the slit lamp illumination and focused on the same Each of the devices features operator plane. protective filters that prevent laser treatment radiation from reaching the eyes of the user. In each case, the position of the laser spot within the focal plane is moveable using a micromanipulater.

The technological characteristics, intended use, materials, design, method of manufacture, and labeling of the device is substantially equivalent to those of the predicate devices.

### Conclusion:

The BQ/BM Laser Delivery System does not raise new questions of safety and effectiveness and is substantially equivalent to the Rodenstock Ro 5000 AR/FDY and the Zeiss 130 SL.

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Public Health Service

MAY 17 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel Hoefer Regulatory Affairs American Laser Corporation 2417 South 3850 West Salt Lake City, Utah 84120

K990665 Re:

> Trade Name: BQ/BM Integrated Laser Delivery System Regulatory Class: II Product Code: HQF Dated: March 1, 1999 Received: March 2, 1999

Dear Mr. Hoefer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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# Page 2 – Mr. Daniel Hoefer

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 6 ol 7

• .

510(k) Number lif known): K 990 k b b

BQ/BM INTEGRATED LASER DELIVERY SYSTEM Device Name:_

Indications For Use:

..

.

1. RETINAL PHOTOCOAGULATION

..

2. TRABECULOPLASTY

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

| Concurrence of CORH, Office of Device Evaluation (ODE) | | | |
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| | (Division Sign-Off) | | |
| | Division of General Restorative Devices | | |
| 510(k) Number | K990665 | | |

Prescription Use \$\varnothing\$ OR Over The-Counter Use ____

(Per 21 CFR 801.109)

:Optical Format 1-2-361

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