# K020374: Oculight SL/SLX

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: May 3, 2002 after 88 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: 2 generations back to K894841 (1989). 8 ancestors in all.
69 later devices descend from it; 9 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894841: Iris Oculight (TM) SL, Iriderm Div. (1989) Summary page 1.
- K913430: Iris Oculight (R) SLX, Iriderm Div. (1991) Summary page 1.
- K960971: Oculight GL, Iriderm Div. (1996) Summary page 1.
- K890086: Microlase 8 0 0  (Ophthalmic Laser), Keeler Instruments, Inc. (1989) Summary page 1.
- K013760: DC-3300 Laser Diode Photocoagulator, Nidek, Inc. (2002). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K043486: Pascal Photocoagulator, Product-Pascal-01 (2005), 29 descendants of its own
- K091666: Pascal Photocoagulator, Pascal-US (2009), 23 descendants of its own
- K092621: Pascal Streamline Photocoagulator (2009), 22 descendants of its own
- K031665: Iris Medical Oculight GL/GLX Laser Systems (2003), 21 descendants of its own
- K062624: Next Generation Laser (2007), 18 descendants of its own

## Indications for use
The IRIDEX OcuLight SL/SLx 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 OcuLight SL/SLx laser systems. Condition: Diabetic Retinopathy Treatment: Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments Condition: Glaucoma Treatment: Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation Condition: Retinal Tears, Detachments, and Holes Treatment: Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments Condition: Lattice Degeneration Treatment: PRP; Focal and Grid Laser Treatments Condition: Age-related Macular Degeneration (AMD) Treatment: Focal and Grid Laser Treatments Condition: Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma) Treatment: Focal and Grid Laser Treatments Condition: Retinopathy of Prematurity Treatment: PRP; TSRPC; Focal and Grid Laser Treatments Condition: Sub-Retinal (choroidal) Neovascularization Treatment: Focal and Grid Laser Treatments Condition: Central and Branch Retinal Vein Occlusion Treatment: PRP; Focal and Grid Laser Treatments

Source page: https://510kreport.com/device/K020374
Methodology: https://510kreport.com/methodology