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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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