# K081946: Supra Twin Ophthalmic Laser Photocoagulator

- Pathway: 510(k) (Special)
- Applicant: Quantel Medical
- Decided: Mar 25, 2009 after 260 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894841 (1989). 18 ancestors in all.
2 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)
- K070776: Supra Ophthalmic Laser Photocoagulator, Quantel Medical (2007) Summary page 1.
- K023464: Viridis Twin Ophthalmic Photocoagulator, Quantel Medical (2003) Summary page 1.

## Most influential descendants
- K201502: Vitra 810 (2020), 0 descendants of its own
- K152688: LightLas Multi-Wavelength Medical Laser System (2016), 0 descendants of its own

## Indications for use
The Supra Twin Ophthalmic Laser Photocoagulator wavelength 532nm is indicated for retinal photocoagulation in the following conditions: With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments. With an endocular probe - for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy. With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments. The Supra Twin Ophthalmic Laser Photocoagulator wavelength 81 Onm is indicated for use for: Phocoagulation 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 choroidal neovasculature, and Age related macular degeneration (AMD) treatments.

Source page: https://510kreport.com/device/K081946
Methodology: https://510kreport.com/methodology