OCULIGHT GL/GLX

K050562 · Iridex Corp · GEX · Apr 14, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050562
• Device Name: OCULIGHT GL/GLX
• Applicant: Iridex Corp
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty, the treatment of vascular and pigmented skin lesions, stapedotomy, stapedectomy, and other ear, nose, and throat (ENT) applications. The following are examples of applications for the OcuLight GL/GLx laser systems. Condition Treatment Diabetic Retinopathy Retinal Photocoagulation (RPC); Focal and Grid Laser Treatments Nonproliferative Retinopathy Macular Edema Proliferative Retinopathy Glaucoma Laser Trabeculoplasty; Iridotomy; Iridoplasty Primary Open Angle Closed Angle Refractory Glaucoma Retinal Tears and Detachments RPC; Focal and Grid Laser Treatments Lattice Degeneration RPC; Focal and Grid Laser Treatments Age-related Macular Degeneration (AMD) RPC; Focal and Grid Laser Treatments Intra-Ocular Tumors RPC; Focal and Grid Laser Treatments Choroidal Hemangioma Choroidal Melanoma Retinoblastoma Retinopathy of Prematurity RPC; Focal and Grid Laser Treatments Sub-Retinal (choroidal) Neovascularization RPC; Focal and Grid Laser Treatments Central and Branch Retinal Vein Occlusion RPC; Focal and Grid Laser Treatments Dermatology Focal Laser Treatments Pigmented Skin Lesions Vascular lesions Ear, Nose and Throat Otosclerotic hearing loss and/or diseases of the inner ear Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft tissue Adhesion in Micro/Macro Otologic Procedures

Device Story

Semiconductor-based laser system delivering continuous wave green (532 nm) laser light for photocoagulation and surgical applications; visible red (630-650 nm) diode laser used for aiming. Operated by clinicians in ophthalmic, dermatological, and ENT settings. Device transforms electrical energy into laser output for tissue interaction (photocoagulation, ablation, or hemostasis). Healthcare providers use the laser to treat ocular conditions, skin lesions, and ENT pathologies. Output affects clinical decision-making by providing a therapeutic tool for tissue management, potentially benefiting patients by addressing vision-threatening conditions, skin lesions, and otologic diseases.

Clinical Evidence

No clinical data.

Technological Characteristics

Semiconductor-based laser system; 532 nm green laser for treatment; 630-650 nm red diode laser for aiming; continuous wave delivery; hardware and firmware unchanged from previous versions.

Indications for Use

Indicated for patients requiring retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty, treatment of vascular/pigmented skin lesions, or ENT procedures including stapedotomy, stapedectomy, myringotomies, lysis of adhesions, bleeding control, and removal of acoustic neuromas. Applicable to conditions including diabetic retinopathy, glaucoma, retinal tears/detachments, lattice degeneration, AMD, intra-ocular tumors, retinopathy of prematurity, sub-retinal neovascularization, and retinal vein occlusion.

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

• OcuLight SL/SLx laser systems
• Lumenis Novus Spectra (K022327)

Submission Summary (Full Text)

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# APR 1 4 2005

# 510(k) Summary IRIDEX Corporation IRIS Medical® OcuLight® GL/GLx

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

John Jossy IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 [phone] ext. 3016

Contact Person: (same as above)

Date Prepared: May 23, 2003

## Name of Device and Name/Address of Sponsor

IRIS Medical OcuLight GL/GLx Laser Systems

IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043

### Classification Name

Laser Instrument, Surgical, Powered CFR Section: 878.4810 and 886.4390 Product Code: GEX and HQF

### Predicate Devices

The OcuLight GL/GLx laser systems are substantially equivalent to other currently legally marketed ophthalmology laser devices including Ocutiight SLASLASE systems and the Lumenis Novus Spectra (K022327).

### Device Description

The OcuLight GL/GLx is a semiconductor-based laser that delivers true continuous wave green laser (532 nm) light for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. Visible red (630-650 nm) semiconductor diode laser is used for aiming.

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## Intended Use

The OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty, the treatment of vascular and pigmented skin lesions, stapedotomy, stapedectomy, and other ear, nose, and throat (ENT) applications. The following are examples of applications for the OcuLight GL/GLx laser systems.

| Condition | Treatment |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diabetic Retinopathy | Retinal Photocoagulation (RPC); Focal<br>and Grid Laser Treatments |
| Nonproliferative Retinopathy Macular Edema Proliferative Retinopathy | |
| Glaucoma | Laser Trabeculoplasty; Iridotomy;<br>Iridoplasty |
| Primary Open Angle Closed Angle Refractory Glaucoma | |
| Retinal Tears and Detachments | RPC; Focal and Grid Laser Treatments |
| Lattice Degeneration | RPC; Focal and Grid Laser Treatments |
| Age-related Macular Degeneration (AMD) | RPC; Focal and Grid Laser Treatments |
| Intra-Ocular Tumors | RPC; Focal and Grid Laser Treatments |
| Choroidal Hemangioma Choroidal Melanoma Retinoblastoma | |
| Retinopathy of Prematurity | RPC; Focal and Grid Laser Treatments |
| Sub-Retinal (choroidal) Neovascularization | RPC; Focal and Grid Laser Treatments |
| Central and Branch Retinal Vein Occlusion | RPC; Focal and Grid Laser Treatments |
| Dermatology | Focal Laser Treatments |
| Pigmented Skin Lesions Vascular lesions | |
| Ear, Nose and Throat | |
| Otosclerotic hearing loss and/or diseases<br>of the inner ear | Stapedectomy<br>Stapedotomy<br>Myringotomies<br>Lysis of Adhesions<br>Control of Bleeding<br>Removal of Acoustic Neuromas<br>Soft tissue Adhesion in Micro/Macro<br>Otologic<br>Procedures |

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## Technological Characteristics and Substantial Equivalence

The OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty, the treatment of vascular and pigmented skin lesions, stapedotomy, stapedectomy, and other ENT applications. The expansion of the indications for use for the proposed OcuLight does not result in a change to the hardware or firmware for the currently marketed OcuLight GL/GLx.

The OcuLight SL/SLx Laser Systems are indicated for Retinal Photocoagulation, Laser Trabeculoplasty, Transscleral Cyclophotocoagulation (TSCPC), Transscleral Retinal Photocoagulation (TSRPC), Iridotomy, and Iridoplasty. The OcuLight SL/SLx diode laser systems feature a combination of pulsed diode laser and optical fiber technology to deliver the correct balance of 810 nm wavelength, spot size, and pulse duration for effective laser photocoagulation.

The Lumenis Novus Spectra Diode Laser System is indicated for many Ophthalmic, Ears, Nose and Throat (including stapedectomy), Dermatological and Dentistry applications. The Lumenis Novus Spectra delivers the same 532nm wavelength, pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight GL/GLx.

## Non-Clinical performance Data

None

## Clinical performance Data

None

## Conclusion

The OcuLight GL/GLx is substantially equivalent to the predicate devices currently legally marketed for stapedotomy, stapedectomy, and other ENT applications as shown in the Indications for Use statement.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2005

IRIDEX Corporation c/o John Jossy Director of Regulatory Affairs and Quality Assurance 1212 Terra Bella Avenue Mountain View, CA 04043

Re: K050562

Trade/Device Name: IRIS Medical OcuLight GL/GLx Laser Systems 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: March 4, 2005 Received: March 8, 2005

Dear Mr. Jossy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to back at 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 r that FDA has made a determination that your device complies with other requirements of the Act that I D. I has intacted and regulations administered by other Federal agencies. You must or any I cuttar statutes and registanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quants of byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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,

David M. Whipple

Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

Kosos62 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known): Pending_____________________________________________________________________________________________________________________________________________

Device Name: IRIS Medical® OcuLight® GL/GLx

Indications For Use:

The IRIDEX OcuLight GL/GLx is used in ophthalmic, dermatology, and ear nose and throat (ENT) applications. Specific indications are listed below:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Condition | Treatment |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Diabetic Retinopathy<br>• Nonproliferative Retinopathy<br>• Macular Edema<br>• Proliferative Retinopathy | Retinal Photocoagulation (RPC); Focal and Grid Laser Treatments |
| Glaucoma<br>• Primary Open Angle<br>• Closed Angle | Laser Trabeculoplasty; Iridotomy, Iridoplasty |
| Retinal Tears and Detachments | RPC; Focal and Grid Laser Treatments |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

{6}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Pending_____________________________________________________________________________________________________________________________________________

Device Name: IRIS Medical® OcuLight® GL/GLx __________________________________________________________________________________________________________________________________

Indications For Use:

| Condition | Treatment |
|-------------------------------------------------------------------------------------------|--------------------------------------|
| Lattice Degeneration | RPC; Focal and Grid Laser Treatments |
| Age-related Macular Degeneration (AMD) | RPC; Focal and Grid Laser Treatments |
| Intra-Ocular Tumors<br>• Choroidal Hemangioma<br>• Choroidal Melanoma<br>• Retinoblastoma | RPC; Focal and Grid Laser Treatments |
| Retinopathy of Prematurity | RPC; Focal and Grid Laser Treatments |
| Sub-Retinal (choroidal) Neovascularization | RPC; Focal and Grid Laser Treatments |
| Central and Branch Retinal Vein Occlusion | RPC; Focal and Grid Laser Treatments |

# (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

{7}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Bending Kosos 62 2 2 2 2 2 2 2 2 2 2 ----------

Device Name: IRIS Medical® OcuLight® GL/GLx___________________________________________________________________________________________________________________________________

Indications For Use:

| Condition | Treatment |
|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dermatology<br>• Pigmented Skin Lesions<br>• Vascular lesions | Focal Laser Treatments |
| Ear, Nose and Throat<br>• Otosclerotic hearing loss and/or diseases of the inner ear | Stapedectomy<br>Stapedotomy<br>Myringotomies<br>Lysis of Adhesions<br>Control of Bleeding<br>Removal of Acoustic Neuromas<br>Soft tissue Adhesion in Micro/Macro Otologic Procedures |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span style="text-decoration: overline;">✓</span> </div> |
|------------------|----------------------------------------------------------------|
| | OR |
| | (Per 21 CFR 801.109) |

forex & to hom
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________