# K121475: Txcell Scanning Laser Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: Nov 28, 2012 after 194 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: 8 generations back to K894841 (1989). 29 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 36 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 2.
- K100678: Supra Scan Delivery System, Quantel Medical (2010) Summary page 2.
- K111108: Pascal Streamline 577 (with Accessories), Topcon Medical Laser Systems, Inc. (2011) Summary page 2.

## Most influential descendants
- K123542: Pascal Synthesis (532NM/577NM) Opthalmic Laser (2013), 5 descendants of its own
- K141851: Navilas Laser System (2015), 2 descendants of its own
- K223132: Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) (2022), 1 descendant of its own
- K162191: NAVILAS Laser System (2016), 1 descendant of its own
- K251772: Navilas Laser System 577sl (156691) (2025), 0 descendants of its own

## Indications for use
When the TxCell Scanning Laser Delivery System is connected to the 1Q0532 (532 nm), the 10 577 (577 nm) or the IQ0810 (810 nm) Laser Console, from the IRIDEX Family of IQ Laser Systems and used to deliver laser energy in CW-Pulse, MicroPulse or LongPulse mode, it is intended to be used by a trained ophthalmologist for the treatment of ocular pathology of both the anterior and posterior segments of the eye. 532 nm Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including: Retinal photocoagulation (RPC) for the treatment of: Diabetic retinopathy, including: Nonproliferative retinopathy Macular edema Proliferative retinopathy Retinal tears and detachments Lattice degeneration Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) Sub-retinal (choroidal) neovascularization Central and branch retinal vein occlusion Laser trabeculoplasty for the treatment of: Primary open angle glaucoma Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma 577 nm Indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation of vascular and structure abnormalities of the retina and choroid including: Proliferative and nonproliferative diabetic retinopathy Choroidal neovascularization Branch retinal vein occlusion Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) Retinal tears and detachments Laser trabeculoplasty for the treatment of: Primary open angle glaucoma Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma 810 nm Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy including: Retinal photocoagulation for the treatment of: Diabetic retinopathy, including: Nonproliferative retinopathy Macular edema Proliferative retinopathy Retinal tears, detachments and hole Lattice degeneration Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) Sub-retinal (choroidal) neovascularization Central and branch retinal vein occlusion Laser trabeculoplasty for the treatment of: Primary open angle glaucoma Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma

Source page: https://510kreport.com/device/K121475
Methodology: https://510kreport.com/methodology