# K023094: Iridis Ophthalmic Photocoagulator

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Dec 17, 2002 after 90 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: 3 generations back to K894841 (1989). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020374: Oculight SL/SLX, Iridex Corp (2002) Summary page 1.
- K013760: DC-3300 Laser Diode Photocoagulator, Nidek, Inc. (2002)

## Indications for use
The Quantel Iridis Ophthalmic Photocoagulator is indicated for the photocoagulation or ablation of pigmented tissue within the eye. Examples include: photocoagulation 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/K023094
Methodology: https://510kreport.com/methodology