# K230228: Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)

- Pathway: 510(k) (Special)
- Applicant: Iridex Corporation
- Decided: Feb 23, 2023 after 27 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: 1 generation back to K071687 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 5.

## Indications for use
The Iridex® Laser Console (532 model and 577 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse) or MicroPulse® mode, for ophthalmic applications (532 and 577 models) and for Ear, Nose, and Throat (Otolaryngology) applications (532 model only). Iridex® 532 Laser The Iridex® 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, ear, nose and throat (ENT)/otolaryngology, and ophthalmology as follows: Ophthalmology Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including: • Retinal photocoagulation (RPC) for the treatment of o Diabetic retinopathy, including: Nonproliferative retinopathy Macular edema Proliferative retinopathy o Retinal tears and detachments o Lattice degeneration o Age-related macular degeneration (AMD) o Retinopathy of prematurity o Sub-retinal (choroidal) neovascularization o Central and branch retinal vein occlusion • Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including o Primary open angle/Closed angle Ear, Nose, and Throat (ENT)/Otolaryngology Otosclerotic Hearing loss and/or diseases of the inner ear: • Stapedectomy • Stapedotomy • Myringotomies • Lysis of Adhesions • Control of Bleeding • Removal of Acoustic Neuromas • Soft tissue Adhesion in Micro/Macro Otologic Procedures Iridex® 577 Laser The Iridex® 577 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialty of ophthalmology as follows: Ophthalmology Indicated for use in photocoagulation of both anterior and posterior segments including: • Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and nonproliferative diabetic retinopathy o Choroidal neovascularization o Branch retinal vein occlusion o Age-related macular degeneration (AMD) o Retinal tears and detachments o Retinopathy of prematurity • Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Source page: https://510kreport.com/device/K230228
Methodology: https://510kreport.com/methodology