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The Viridis Twin laser is indicated for the photocoagulation or ablation of pigmented tissue within the eye.

The 532 nm wavelength is indicated for use for:

retinal photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. peripheral photocoagulation proliferative diabetic retinopathy, macular degeneration, and retinal detachment. endophotocoagulation (EPCP) intraocular photocoagulation as an adjunct in vitrectomy surgery, complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, retinopathy, and retinal vascular tumors.

The 810 nm wavelength is indicated for use for:

photocoagulation or ablation of pigmented tissue within the eye, transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments), limited and pan-retinal photocoagulation, transpupillary photocoagulation, endophotocoagulation, treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choriodal neovasculature, and age-related macular degeneration (AMD) treatments.

The Viridis Twin Ophthalmic Photocoagulator is a combination system consisting of a Nd:YAG frequency doubled laser which emits a beam of coherent light at 532 nm and a diode laser which emits a beam of coherent light 810 microns. The treatment beam is selected by the user, the delivery system is attached to the appropriate laser aperture, and the energy is delivered to the treatment site(s) via delivery systems/devices.

The provided text indicates that no performance data was required for the Viridis Twin Ophthalmic Photocoagulator. The FDA's 510(k) summary states, "Performance Data: None required." The conclusion of the 510(k) summary is based on the substantial equivalence of the Viridis Twin Ophthalmic Photocoagulator to legally marketed predicate devices, not on a study proving the device meets specific acceptance criteria through performance metrics.

Therefore, I cannot populate the table or provide information about a study proving the device meets acceptance criteria because the submission explicitly states that performance data was not required. The approval was based on substantial equivalence to predicate devices, not on the demonstration of specific performance metrics or clinical study results.

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The Quantel Iridis Ophthalmic Photocoagulator is indicated for the photocoagulation or ablation of pigmented tissue within the eye. Examples include: photocoagulation of pigmented tissue within the eye, transscleral ciliary body ablation (treatment is reserved for patients with chronic glaucoma and those not responding to conventional treatments), limited and pan-retinal photocoagulation, transpupillary photocoagulation, endophotocoagulation, treatment of complicated rhegmatogeous, tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, macular degeneration, peripheral photocoagulation (recumbent patients), transpupillary photocoagulation of choriodal neovasculature, and age-related macular degeneration (AMD) treatments.

The Iridis Ophthalmic Photocoagulator consists of a main console with controls and a foot switch. The laser emits a coherent beam of light at 810 nm. Delivery systems attached to the laser then transmit the beam to treatment sites within the eye. The delivery systems are independent devices, manufactured by independent manufacturers, which attach to the Iridis Ophthalmic Photocoagulator either by direct connection at the laser aperture or through attachments, such as the slit lamp adapter.

This document, a 510(k) summary for the Iridis Ophthalmic Photocoagulator, does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy or meet specific performance criteria through a dedicated study.

Here's a breakdown of why the requested information cannot be found in the provided text:

• Acceptance Criteria and Reported Device Performance: This document states "Performance Data: None required." (Section 1). This explicitly indicates that specific performance data, including acceptance criteria and how the device met them, was not part of this submission.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set): Since "Performance Data: None required" was stated, there is no mention of any study that would typically involve these elements. The submission relies on demonstrating substantial equivalence to predicate devices based on design and intended use, rather than a clinical or performance study.

In summary, none of the requested information regarding acceptance criteria or a study proving the device meets them is present in the provided text. The 510(k) clearance for this device was based on demonstrating substantial equivalence to already legally marketed predicate devices, negating the need for new performance studies in this specific submission.

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