The IRIDEX OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The following are examples of applications for the OcuLight GL/GLx laser systems.

Condition	Treatment
Diabetic Retinopathy	Retinal Photocoagulation (RPC); Focaland 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	Stapedotomy
• Otosclerotic hearing loss

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.

AI/ML Overview

The IRIS Medical® OcuLight® GL/GLx device is a laser system indicated for various medical treatments, primarily in ophthalmology (retinal photocoagulation, laser trabeculoplasty) and also for vascular/pigmented skin lesions and other laser treatments.

1. Table of Acceptance Criteria and Reported Device Performance & 2. Sample Size and Data Provenance & 3. Number and Qualifications of Experts & 4. Adjudication Method & 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study & 6. Standalone Performance & 7. Type of Ground Truth & 8. Sample Size for Training Set & 9. How Ground Truth for Training Set was Established

Based on the provided 510(k) summary, the device's acceptance criteria and performance are established through substantial equivalence to predicate devices, rather than through specific performance metrics from a clinical study on the OcuLight GL/GLx itself.

The document explicitly states:

"Non-Clinical performance Data: None"
"Clinical performance Data: None"

Therefore, the following information cannot be extracted from the provided text:

Acceptance Criteria and Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are provided for the OcuLight GL/GLx within this document. The "acceptance criteria" presented here are implicitly the FDA's determination of substantial equivalence based on the device's technological characteristics and intended use being similar to legally marketed predicate devices.
Sample Size Used for the Test Set and Data Provenance: No test set or associated data is described.
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as no ground truth establishment for a test set is described.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned or referenced.
Standalone Performance: No standalone performance data (algorithm-only) is presented as this is a physical laser device, not an AI or algorithmic diagnostic tool.
Type of Ground Truth Used: Not applicable, as no external ground truth was established for the device's performance in this filing.
Sample Size for the Training Set: Not applicable as this is not an AI/ML device that requires a training set in the conventional sense.
How the Ground Truth for the Training Set was Established: Not applicable.

Study Proving Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" that proves the OcuLight GL/GLx meets the acceptance criteria of the FDA is the application for 510(k) Pre-market Notification, demonstrating Substantial Equivalence (SE) to legally marketed predicate devices.

Predicate Devices asserted by IRIDEX Corporation:

IRIDEX Corporation's IRIS Medical OcuLight GL Laser (K960971 and K982031)
IRIDEX Corporation's IRIS Medical OcuLight SL/SLx Laser (K020374)
Lumenis Novus Spectra (K022327)
Alcon Ophthalas® 532 Laser (K962592)

Reasoning for Substantial Equivalence (as described in the document):

Intended Use: The OcuLight GL/GLx shares the same intended uses as the predicate devices, including retinal photocoagulation, laser trabeculoplasty, treatment of vascular and pigmented skin lesions, and other laser treatments. The document lists numerous specific conditions and treatments, implicitly asserting that these are within the scope of the predicate devices.
Technological Characteristics:
- The OcuLight GL/GLx is described as 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."
- The document explicitly states that "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." This implies the underlying technology is consistent with previous versions.
- Comparisons to specific predicates highlight shared characteristics:
  - Lumenis Novus Spectra: "delivers the same infrared wavelength, pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight GL/GLx." (Note: there seems to be a minor inconsistency here, as OcuLight GL/GLx is described as 532 nm green laser by IRIDEX, and Lumenis Novus Spectra delivers "infrared wavelength" in this comparison. This might suggest the comparison is more general, or a slight error in wording in the summary provided for the Lumenis device description).
  - Alcon Ophthalas 532 Laser: "delivers a similar wavelength [532 nm], pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight GL/GLx." Both use a variety of delivery systems like slit lamps, indirect ophthalmoscopes, and endoprobe handpieces.
  - IRIS Medical OcuLight SL/SLx Laser: Indicated for similar ophthalmic treatments, but uses an 810 nm diode laser. This comparison points to the similarity in intended use for ophthalmic applications, even with a different wavelength for some predicate devices cited.

In conclusion, the 'study' demonstrating the device meets "acceptance criteria" (defined as substantial equivalence to legally marketed devices) is the submission of a 510(k) premarket notification. This notification asserts and provides evidence for the device's similarity in intended use and technological characteristics to existing devices, without presenting new clinical or non-clinical performance data for the OcuLight GL/GLx itself. The FDA reviewed this submission and determined the device was substantially equivalent.

Summary

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

AUG 2 7 2003

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

K031665 1/3

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

John Jossy IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 (650) 962-8848 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 IRIDEX Corporation's IRIS Medical OcuLight GL Laser (K960971 and K982031), the IRIS Medical OcuLight SL/SLx Laser (K020374), the Lumenis Novus Spectra (K022327), and the Alcon Ophthalas® 532 Laser (K962592).

Device Description

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

Intended Use

The OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The following are examples of applications for the OcuLight GL/GLx laser systems.

Condition	Treatment
Diabetic Retinopathy	Retinal Photocoagulation (RPC); Focaland 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	Stapedotomy
• Otosclerotic hearing loss

Technological Characteristics and Substantial Equivalence

The OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. 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.

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

K0.31665 3/3

The OcuLight SL/SLx Laser Systems are indicated for Retinal Photocoagulation, Laser Trabeculoplasty, Transscleral Cyclophotocoagulation, Transscleral Retinal Photocoagulation, and other Laser Diode Treatments. 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, Dermatological and Dentistry applications. The Lumenis Novus Spectra delivers the same infrared wavelength, pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight GL/GLx.

The Alcon Ophthalas 532 Laser is indicated for use in all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation; Internal Sclerostomy; Iridotomy; and Trabeculoplasty. The Ophthalas 532 Laser and OcuLight GL/GLx use a variety of delivery systems, including slit lamps, indirect ophthalmoscopes, and endoprobe handpieces. The Ophthalas 532 Laser delivers a similar 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 predicate devices currently legally marketed for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments.

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

AUG 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Jossy Director of Regulatory Affairs and Quality Assurancae IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, California 94043

Re: K031665

Trade/Device Name: IRIS Medical® OcuLight® GL/GLx Regulation Numbers: 21 CFR 886.4390 Regulation Names: Ophthalmic laser Regulatory Class: II Product Codes: HQF Dated: May 23, 2003 Received: May 29 2003

Dear Mr. Jossy:

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 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.

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

Page 2 - Mr. John Jossy

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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Pending

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

Indications For Use:

Condition	Treatment
Diabetic Retinopathy	Retinal Photocoagulation (RPC); Focaland Grid Laser Treatments
• Nonproliferative Retinopathy
• Macular Edema
• Proliferative Retinopathy
Glaucoma	Laser Trabeculoplasty; Iridotomy,Iridoplasty
• Primary Open Angle
• Closed Angle
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)

Muriam C. Provost

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

510(k) Number K031665

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	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	Stapedotomy
• Otosclerotic Hearing Loss

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number K03/665

Prescription Use .

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

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
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.(b)
Classification. Class II.