(88 days)
The IRIDEX OcuLight SL/SLx is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the OcuLight SL/SLx laser systems.
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy Nonproliferative Retinopathy Macular Edema Proliferative Retinopathy | Panretinal Photocoagulation (PRP); |
| Focal and Grid Laser Treatments | |
| Glaucoma Primary Open Angle Closed Angle Refractory Glaucoma | |
| (recalcitrant/uncontrolled) | Laser Trabeculoplasty; Iridotomy; |
| Transscleral Cyclophotocoagulation (TSCPC) | |
| Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser |
| Treatments | |
| Lattice Degeneration | PRP; Focal and Grid Laser Treatments |
| Age-related Macular Degeneration (AMD) | Focal and Grid Laser Treatments |
| Intra-Ocular Tumors Choroidal Hemangioma Choroidal Melanoma Retinoblastoma | Focal and Grid Laser Treatments |
| Retinopathy of Prematurity | PRP; TSRPC; Focal and Grid Laser |
| Treatments | |
| Sub-Retinal (choroidal) Neovascularization | Focal and Grid Laser Treatments |
| Central and Branch Retinal Vein Occlusion | PRP; Focal and Grid Laser Treatments |
The OcuLight SL/SLx is a semiconductor diode laser system that delivers pulsed infrared 810 nm laser light intended to be used for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other laser diode treatments. Visible red (630-650 nm) semiconductor diode laser is used for aiming.
The provided 510(k) summary for the IRIDEX Corporation IRIS Medical® OcuLight® SL/SLx does not contain information about acceptance criteria or a study proving that the device meets such criteria.
This document is a 510(k) premarket notification, which is a submission to the FDA demonstrating that a device is substantially equivalent to a legally marketed predicate device. For such submissions, the primary focus is on demonstrating equivalence rather than establishing new performance criteria through extensive clinical trials as might be required for a novel device or a PMA.
Here's a breakdown of why the requested information is absent based on the provided text:
- Non-Clinical performance Data: States "None"
- Clinical performance Data: States "None"
The submission explicitly states that no non-clinical or clinical performance data was provided. Instead, the justification for marketing the device is based on its substantial equivalence to existing predicate devices. This means the device is considered safe and effective because it shares similar technological characteristics and intended uses with devices already cleared by the FDA.
Therefore, the requested information cannot be extracted from this document, and the following points would be Not Applicable (N/A) for this particular submission:
- A table of acceptance criteria and the reported device performance: N/A (No acceptance criteria or performance data reported)
- Sample size used for the test set and the data provenance: N/A (No test set mentioned)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No test set or ground truth mentioned)
- Adjudication method for the test set: N/A (No test set mentioned)
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (No MRMC study mentioned; this is not an AI device)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is a laser device, not an algorithm)
- The type of ground truth used: N/A (No ground truth mentioned)
- The sample size for the training set: N/A (No training set mentioned; this is a physical device)
- How the ground truth for the training set was established: N/A (No training set mentioned)
§ 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.