# K100678: Supra Scan Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Jul 21, 2010 after 133 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: 5 generations back to K894841 (1989). 22 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081744: Pascal Synthesis Delivery System, Optimedica Corporation (2008) Summary page 2.

## 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
- K162191: NAVILAS Laser System (2016), 1 descendant of its own

## Indications for use
The SUPRA SCAN™ Delivery System when connected to a compatible laser system is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormualities of the retina and choroids including: * Proliferative and nonproliferative diabetic retinopathy; * Choroidal neovascularization; * Branch retinal vein occlusion; * Age-related macular degeneration; * Retinal tears and detachments * Macular edema * Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

Source page: https://510kreport.com/device/K100678
Methodology: https://510kreport.com/methodology