# K111108: Pascal Streamline 577 (with Accessories)

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Laser Systems, Inc.
- Decided: Aug 11, 2011 after 113 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: 7 generations back to K894841 (1989). 26 ancestors in all.
15 later devices descend from it; 7 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100019: Pascal Streamline Photocoagulator, Optimedica Corporation (2010) Summary page 1.
- K091581: Supra 577.Y Laser, Quantel Medical (2009) Summary page 1.
- K071687: Famili of Iridex IQ Laser Systems, Iridex Corp (2008) Summary page 1.

## Most influential descendants
- K121475: Txcell Scanning Laser Delivery System (2012), 6 descendants of its own
- 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
- K171488: PSLT for PASCAL Streamline (2017), 1 descendant of its own

## Indications for use
PASCAL® Streamline 577 (with Accessories) is intended for use in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: a proliferative and nonproliferative diabetic retinopathy *macular edema *choroidal neovascularization *branch and central retinal vein occlusion * the treatment of choroidal neovascularization associated with wet age-related macular degeneration *lattice degeneration *retinal tears and detachments *retinopathy of prematurity Intended for use in the treatment of ocular pathology in the anterior segment including: * iridotomy * trabeculoplasty

Source page: https://510kreport.com/device/K111108
Methodology: https://510kreport.com/methodology