# K213592: Iridex 810 Laser

- Pathway: 510(k) (Special)
- Applicant: Iridex Corporation
- Decided: Mar 23, 2022 after 131 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202760: Iridex 810 Laser, Iridex Corporation (2020) Summary page 5.
- K162416: IRIDEX Cyclo G6 Laser System, G-Probe Illuminate, Iridex Corporation (2016) Summary page 5.
- K143154: IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID), Iridex Corporation (2015) Summary page 5.

## Indications for use
The Iridex 810 Laser is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser. CONDITION TREATMENT Diabetic Retinopathy Panretinal Photocoagulation (PRP); *Nonproliferative Retinopathy Focal and Grid Laser Treatments * Macular Edema * Proliferative Retinopathy Glaucoma Laser Trabeculoplasty; Iridotomy; * Primary Open Angle Transscleral Cyclophotocoagulation (TSCPC) * Closed Angle * Refractory Glaucoma (recalcitrant/uncontrolled) 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) Focal and Grid Laser Treatments Intra-Ocular Tumors Focal and Grid Laser Treatments * Choroidal Hemangioma * Choroidal Melanoma * Retinoblastoma 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/K213592
Methodology: https://510kreport.com/methodology