# K111643: Opto Mitra Yellow Laser

- Pathway: 510(k) (Traditional)
- Applicant: Opto Electronica SA
- Decided: Nov 3, 2011 after 143 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). 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)
- K071687: Famili of Iridex IQ Laser Systems, Iridex Corp (2008) Summary page 2.
- K110228: Nidek Multicolor Laser Photocoagulator, Nidek Incorporated (2011) Summary page 2.

## Indications for use
The Opto Mitra Yellow Laser is indicated for retinal photocoagulation. Used for the following ophthalmic medical condition end treatment: Retinal photocoagulation, panretinal photocoagulation and intravitreal endlophotocoagulation of vascular and structural abnormalities of the retina and choroids, including: Proliferative and nonproliferative diabetic retinopathy Choroidal neovascularization Branch retinal vein occlusion The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments Retinopathy of prematurity ridlotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Source page: https://510kreport.com/device/K111643
Methodology: https://510kreport.com/methodology