# K050562: Oculight GL/GLX

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: Apr 14, 2005 after 42 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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 K022327 (2002). 1 ancestor in all.
75 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022327: Novus Spectra, Lumenis, Inc. (2002) Summary page 1.
- (no number) OcuLight SL/SLx Laser Systems: named in the summary without a submission number

## Most influential descendants
- K062369: Iridex Oculight TX (2006), 73 descendants of its own
- K091534: Lightlas Model 532 (2009), 72 descendants of its own
- K100558: Quanta Diode Laser System (2010), 68 descendants of its own
- K102755: Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser (2010), 46 descendants of its own
- K110080: Radial-Emitting Shaped Fiber Optic Delivery System (2011), 26 descendants of its own

## Indications for use
The IRIDEX OcuLight GL/GLx is used in ophthalmic, dermatology, and ear nose and throat (ENT) applications. Specific indications are listed below: Condition: Diabetic Retinopathy * Nonproliferative Retinopathy * Macular Edema * Proliferative Retinopathy Treatment: Retinal Photocoagulation (RPC); Focal and Grid Laser Treatments Condition: Glaucoma * Primary Open Angle * Closed Angle Treatment: Laser Trabeculoplasty; Iridotomy, Iridoplasty Condition: Retinal Tears and Detachments Treatment: RPC; Focal and Grid Laser Treatments Condition: Lattice Degeneration Treatment: RPC; Focal and Grid Laser Treatments Condition: Age-related Macular Degeneration (AMD) Treatment: RPC; Focal and Grid Laser Treatments Condition: Intra-Ocular Tumors * Choroidal Hemangioma * Choroidal Melanoma * Retinoblastoma Treatment: RPC; Focal and Grid Laser Treatments Condition: Retinopathy of Prematurity Treatment: RPC; Focal and Grid Laser Treatments Condition: Sub-Retinal (choroidal) Neovascularization Treatment: RPC; Focal and Grid Laser Treatments Condition: Central and Branch Retinal Vein Occlusion Treatment: RPC; Focal and Grid Laser Treatments Condition: Dermatology * Pigmented Skin Lesions * Vascular lesions Treatment: Focal Laser Treatments Condition: Ear, Nose and Throat * Otosclerotic hearing loss and/or diseases of the inner ear Treatment: Stapedectomy; Stapedotomy; Myringotomies; Lysis of Adhesions; Control of Bleeding; Removal of Acoustic Neuromas; Soft tissue Adhesion in Micro/Macro Otologic Procedures

Source page: https://510kreport.com/device/K050562
Methodology: https://510kreport.com/methodology