(90 days)
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); 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 | Stapedotomy |
| • Otosclerotic hearing loss |
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):
- 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.
§ 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.