# K031665: Iris Medical Oculight GL/GLX Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: Aug 27, 2003 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: 4 generations back to K933880 (1994). 19 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960971: Oculight GL, Iriderm Div. (1996) Summary page 1.
- K982031: Oculight GL with the Dermatology Handpiece, Iridex Corp (1998)
- K020374: Oculight SL/SLX, Iridex Corp (2002) Summary page 1.
- K022327: Novus Spectra, Lumenis, Inc. (2002) Summary page 1.
- K962592: Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser Systems, Alcon Laboratories (1996) Summary page 1.

## Most influential descendants
- K062624: Next Generation Laser (2007), 18 descendants of its own
- K101285: Constellation Vision System (2010), 17 descendants of its own
- K121555: Centurion Vision System (2012), 6 descendants of its own
- K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector) (2015), 5 descendants of its own
- K161794: CENTURION Vision System (Active SentryTM) (2017), 3 descendants of its own

## Indications for use
The RIDEX OcuLight CUGLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The following are examples of appkatioas for the OcuLight GWGLx laser systems. Condition Treatment Diabetic Retinopathy Retinal Photocoagulation (RPC); Focal Nonproliferative Retinopathy and Chid Laser Treatments MacularEdema Proliferative Retinopathy Glaucoma Laser Trabeculoplasty; Iridotomy, Primary Open Angle Jiidoplasty Closed Angle Retinal Tears and Detachments RPC; Focal and Grid Laser Treatments Condition Treatment Lattice Degeneration FWC; Focal and Grki Laser Treatments Age-related Macular Degeneration (AMD) RPC; Focal and Grid Laser Treatments Intra-Ocular Tumors RPC;Focal and Grid Laser Treatments Choroidal Hemangioma Choroidal Melanoma Retinoblastoma Retinopathy of Prematurity RPC; Focal and Grid Laser Treatments Sub-Retinal (choroidal) Neovasculaiization RPC; Focal and Grid Laser Treatments Central and Branch Retinal Vein Occlusion RPC; Focal and Grid Laser Treatments Dermatology Focal Laser Treatments Pigmented Skin Lesions Vascular lesions Ear, Nose and Throat Stapedotomy Otosclerotic Wearing t o s s

Source page: https://510kreport.com/device/K031665
Methodology: https://510kreport.com/methodology