# K023464: Viridis Twin Ophthalmic Photocoagulator

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Jan 13, 2003 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894841 (1989). 13 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960867: Frequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled ND:Yag Photocoagulator (Evergreen 532), B.V. Intl. S.A. (1996) Summary page 1.
- K991258: Novus Verdi Delivery Systems, Lumenis, Inc. (1999) Summary page 1.
- K020374: Oculight SL/SLX, Iridex Corp (2002) Summary page 2.
- K013760: DC-3300 Laser Diode Photocoagulator, Nidek, Inc. (2002)

## Most influential descendants
- K043236: Frequency Doubled ND: Yag Photocoagulator, Model Vitra (2005), 6 descendants of its own
- K070776: Supra Ophthalmic Laser Photocoagulator (2007), 3 descendants of its own
- K081946: Supra Twin Ophthalmic Laser Photocoagulator (2009), 2 descendants of its own
- K122251: Vitra Multispot (2013), 1 descendant of its own
- K201502: Vitra 810 (2020), 0 descendants of its own

## Indications for use
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 8 10 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.

Source page: https://510kreport.com/device/K023464
Methodology: https://510kreport.com/methodology