# K040209: Iris Medical IQ 810 Photocoagulator

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: Sep 20, 2004 after 234 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 5.

## Indications for use
The IRIDEX IQ 810 is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, and other laser diode treatments. The following are examples of applications for the IQ 810. Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy): Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments Glaucoma (Primary Open Angle, Closed Angle, Refractory Glaucoma [recalcitrant/uncontrolled]): Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC) Retinal Tears, Detachments, and Holes: Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments Lattice Degeneration: PRP; Focal and Grid Laser Treatments Age-related Macular Degeneration (AMD) with Choroidal Neovascularization (CNV): Focal and Grid Laser Treatments Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma): Focal and Grid Laser Treatments Retinopathy of Prematurity: PRP; TSRPC; Focal and Grid Laser Treatments Sub-Retinal (choroidal) Neovascularization: Focal and Grid Laser Treatments Central and Branch Retinal Vein Occlusion: PRP; Focal and Grid Laser Treatments

Source page: https://510kreport.com/device/K040209
Methodology: https://510kreport.com/methodology