# K081744: Pascal Synthesis Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Optimedica Corporation
- Decided: Sep 9, 2008 after 82 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: 4 generations back to K894841 (1989). 21 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043486: Pascal Photocoagulator, Product-Pascal-01, Topcon Medical Laser Systems, Inc. (2005) Summary page 1.
- K971950: Infinitech Multi-Spot Slit Lamp Laser Adapter, Infinitech, Inc. (1997) Summary page 1.

## Most influential descendants
- K100678: Supra Scan Delivery System (2010), 11 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
- K100035: Model Visulas 532S Laser with the Vite Option (2010), 4 descendants of its own
- K181682: VISULAS green (2019), 2 descendants of its own

## Indications for use
The PASCAL Synthesis Delivery System is a stand alone scanning delivery system that, when connected to compatible commercially available laser photocoagulators, allows fully functional scanning photocoagulation. When connected to a compatible laser system, the PASCAL Synthesis Delivery System is indicated for use in the treatment of ocular pathology in both the posterior and anterior segments, retinal photocoagulation, pan retinal 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 * Iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma.

Source page: https://510kreport.com/device/K081744
Methodology: https://510kreport.com/methodology