NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY

K972561 · American Laser Medical · GEX · Oct 6, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972561
• Device Name: NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY
• Applicant: American Laser Medical
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuvoLase 660 Laser System is intended for use in retinal and macular photocoagulation and trabeculoplasty.

Device Story

NuvoLase 660 is a continuous wave frequency-doubled diode-pumped Nd:YAG laser system. It generates 532 nm green laser light by optically pumping an Nd:YAG crystal with 808 nm diodes and passing the resulting 1064 nm light through a non-linear optical crystal. The system features an adjustable treatment beam (max 2.0 Watts) and a 670 nm red diode aiming beam. Exposure durations are selectable (0.02 to 1.0 seconds or continuous). The laser energy is delivered via a fiber optic cable connected to a Rodenstock RO 5000 LS laser slit lamp. Operated by ophthalmologists in clinical settings, the device allows for precise photocoagulation of retinal/macular tissue and trabeculoplasty. The clinician uses the slit lamp optics to visualize the target tissue and apply the laser energy to achieve therapeutic effects, such as tissue coagulation or structural modification, benefiting patients with retinal or glaucoma-related conditions.

Clinical Evidence

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

Technological Characteristics

Continuous wave frequency-doubled diode-pumped Nd:YAG laser; 532 nm treatment wavelength; 670 nm red diode aiming beam; max 2.0W output; fiber optic delivery via slit lamp; mechanical or electro-optical shuttering for exposure control.

Indications for Use

Indicated for retinal and macular photocoagulation and trabeculoplasty in patients requiring ophthalmic laser treatment.

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

• Prima 532 (Nidek, Inc.)
• Oculight GL (IRIS Medical Instruments)

Submission Summary (Full Text)

{0}------------------------------------------------

Nuvo-Lase 660 Laser System American Laser Medical, Inc. July 8, 1997

# 510(k) Summary

97256/

:

## Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

Company Name/Contact:

Daniel Hoefer American Laser Medical رتون 1832 South 3850 West Salt Lake City, UT 84104 [phone], FAX [phone]

# Name of Device:

| Trade Name: | NuvoLase 660 Laser System |
|-------------------------------------------------------------|----------------------------------|
| Common Name: | Ophthalmic Laser Photocoagulator |
| Classification name: Ophthalmic Laser (per 21 CFR 886.4930) | |
| Product Code: 86 HOF | |

# Predicate Devices:

The NuvoLase 660 is substantially equivalent to the following legally marketed devices: The Prima 532 marketed by Nidek, Inc., and the Oculight GL marketed by IRIS Medical Instruments.

# Description of Device:

The NuvoLase Model 660 is a continuous wave frequency-doubled diodepumped Nd: YAG laser system.

{1}------------------------------------------------

Nuvo-Lase 660 Laser System American Laser Medical, Inc. July 8, 1997

> Treatment beam power output for the NuvoLase 660 laser is adjustable to a maximum of 2.0 Watts continuous wave at 532 nm. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 660 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via Rodenstock RO 5000 LS laser slit lamp, connected to the laser by fiber optic.

#### Intended Use:

The NuvoLase 660 Laser System is intended for use in retinal and macular photocoagulation and trabeculoplasty.

#### Technological Characteristics/Device Comparison:

The NuvoLase 660 Laser System is substantially equivalent to the Nidek Prima 532 and the IRIS Oculight GL Laser Photocoagulator already in commercial distribution. Each of these systems optically pumps an Nd: YAG crystal (NuvoLase 660 and Oculight GL using 808 nm diodes, Prima 532 using flashlamps) to produce laser light at 1064 nm. This light passes through a second crystal which exhibits a non-linear optical response, re-emitting the laser energy at the first harmonic of the 1064 nm line, 532 nm green. The continuous wave beam is then shuttered either mechanically or electro-optically to produce the desired exposure durations.

Each of these devices is intended for use in retinal photocoagulation, iridotomy, and trabeculoplasty. Each is a 532 nm true continuous wave device, generated by a frequency doubled diode pumped Nd: YAG crystal. Laser energy is delivered by equivalent delivery devices in each case.

# Conclusion:

The NuvoLase 660 Laser System is substantially equivalent to the Prima 532 marketed by Nidek, Inc. and the Oculight GL marketed by Iris Medical Instruments, already in legal commercial distribution. The materials, design, intended use, method of manufacture, warnings, cautions, and precautions are all substantially the same.

ないという。
『おいしい

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with a staff entwined by a serpent, representing healing and medicine. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel Hoefer American Laser Medical, Inc. 1832 South 3850 West Salt Lake City, Utah 84104

OCT - 6 1007

Re: K972561 Trade Name: NuvoLase 660 Laser System Regulatory Class: II Product Code: GEX Dated: July 8, 1997 Received: July 9, 1997

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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.

{3}------------------------------------------------

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,

Sincerely yours,

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

{4}------------------------------------------------

Page of I

l

.

K972561 `10(k) Number (if known):

.

..

Device Name: NuvoLase 660 Laser System

Indications For Use:

۱۰۰۶

1. Retinal and Macular photocoagulation

2. Trabeculoplasty

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

Concurrence of CDRH, Office of Device Evaluation (OOE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K972561 |

| Prescription Use | <div style="text-align:center;">✓</div> | OR | Over The-Counter Use | |
|----------------------|-----------------------------------------|----|--------------------------|--|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | |