# K201502: Vitra 810

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Aug 6, 2020 after 62 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: 7 generations back to K894841 (1989). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081946: Supra Twin Ophthalmic Laser Photocoagulator, Quantel Medical (2009) Summary page 4.
- K071687: Famili of Iridex IQ Laser Systems, Iridex Corp (2008) Summary page 4.

## Indications for use
The Vitra 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following: * Retinal photocoagulation for the treatment of: o Diabetic retinopathy including: - Nonproliferative retinopathy - Macular edema - Proliferative retinopathy o Retinal Tears, Detachments and Holes o Lattice degeneration o Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) o Retinopathy of prematurity o Sub-retinal (choroidal) neovascularization o Central and Branch Retinal Vein Occlusion » Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation for the treatment of glaucoma, including: o Primary open angle o Closed angle o Refractory Glaucoma (recalcitrant/uncontrolled)

Source page: https://510kreport.com/device/K201502
Methodology: https://510kreport.com/methodology