# K100019: Pascal Streamline Photocoagulator

- Pathway: 510(k) (Traditional)
- Applicant: Optimedica Corporation
- Decided: May 4, 2010 after 119 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894841 (1989). 23 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092621: Pascal Streamline Photocoagulator, Topcon Medical Laser Systems, Inc. (2009) Summary page 1.

## Most influential descendants
- K111108: Pascal Streamline 577 (with Accessories) (2011), 15 descendants of its own
- 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

## Recalls of this device
- Mar 27, 2012 · Class II · Z-1774-2013: When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.

## Indications for use
The PASCAL Streamline Photocoagulator indications for use are the following: 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: * proliferative and nonproliferative diabetic retinopathy * macular edema * choroidal neovascularization * branch and central retinal vein occlusion * age-related macular degeneration * lattice degeneration * retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: * iridotomy * trabeculoplasty

Source page: https://510kreport.com/device/K100019
Methodology: https://510kreport.com/methodology