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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.

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.

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):

1. 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.
2. 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.

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The OcuLight GL is currently cleared for retinal photocoagulation and laser trabeculoplasty using ophthalmic delivery devices (IRIS Slit Lamp Adapter, IRIS Laser Indirect Ophthalmoscope, IRIS EndoProbe). The Dermatology Handpiece will expand the intended use of this device for the treatment of vascular and pigmented skin lesions.

The OcuLight GL is a semiconductor-based dermatology laser system which delivers true continuous wave green laser light. For the additional indication in the treatment of vascular and pigmented lesions it will be used in conjunction with fiber optically coupled Dermatology Handpieces which have received prior FDA-premarket clearance (K964074).

The OcuLight GL is a semiconductor-based laser console which delivers green laser light. The OcuLight GL uses infrared (808 nm) semiconductor diode laser light as the primary source of optical energy which is then wavelength converted to a visible green (532 nm) laser light for the treatment delivery.

A second visible red (630-650 nm) semiconductor CW laser is used for aiming. The 532 nm treatment and 630-650 nm pilot/aiming beams are optically combined inside the laser head and therefore follow the same path. The treatment and aiming beams are coaxial (i.e. follow the same path) in the OcuLight GL. The aiming beam is turned on when the OcuLight is placed into Treat mode.

The delivery devices currently cleared for use with the OcuLight GL are the IRIS Slit Lamp Adapter (SLA), the IRIS EndoProbe, and the IRIS Laser Indirect Ophthalmoscope (LIO). Delivery devices not specifically intended for use with the OcuLight GL will not be recognized by the fiber interlock circuit as a valid delivery device.

For the new indications, the OcuLight GL will utilize the Dermatology Handpieces connected to the fiber port. As was true with the three previously FDA-cleared fiber optically coupled delivery devices used with the OcuLight GL, the distal end of the Dermatology Handpieces will be the laser aperture and not the fiber port on the laser console. The laser port is electronically interlocked so that no laser energy can be emitted without the correct connection of a recognized delivery device.

This 510(k) summary (K982031) describes the IRIS Medical Instruments, Inc. OcuLight GL With Dermatology Handpieces. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices for its intended use in treating vascular and pigmented skin lesions.

The document primarily covers:

• Submitter and Device Information: Name, address, contact, date prepared, FDA registration, device name, and classification.
• Predicate Devices: A list of legally marketed laser systems to which the OcuLight GL is considered substantially equivalent.
• Intended Use: Expansion of the existing OcuLight GL's use to include vascular and pigmented skin lesion treatment with Dermatology Handpieces.
• Device Description: Explanation of the OcuLight GL's technology (semiconductor-based, green laser light, aiming beam) and how it works with the Dermatology Handpieces.
• Technological Characteristics and Substantial Equivalence: A comparison of the OcuLight GL's characteristics (wavelength, power, delivery devices, indications) to the predicate devices to support the claim of substantial equivalence.
• FDA Response Letter: Confirmation of substantial equivalence and market clearance.

Therefore, I cannot populate the requested table and answer the study-related questions from the provided text. The document is strictly a 510(k) submission summary for demonstrating substantial equivalence, not a report on performance studies against acceptance criteria.

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