# K043236: Frequency Doubled ND: Yag Photocoagulator, Model Vitra

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Feb 7, 2005 after 77 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: 4 generations back to K894841 (1989). 16 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 23 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.
- K013402: Visulas 532S, Carl Zeiss, Inc. (2001)
- K023464: Viridis Twin Ophthalmic Photocoagulator, Quantel Medical (2003) Summary page 1.

## Most influential descendants
- 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
- K191962: Vitra 2 (2019), 0 descendants of its own

## Indications for use
The Vitra Ophthalmic Laser Photocoagulator 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.

Source page: https://510kreport.com/device/K043236
Methodology: https://510kreport.com/methodology