# K032598: Synergetics Synerlight Fiber Optic Lightsource

- Pathway: 510(k) (Traditional)
- Applicant: Synergetics, Inc.
- Decided: Nov 24, 2003 after 91 days
- Product code: MPA (Endoilluminator)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964005 (1997). 1 ancestor in all.
38 later devices descend from it; 2 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)
- K964005: Synergetics Synerlight Fiber Optic Lightsource, Synergetics, Inc. (1997) Summary page 1.

## Most influential descendants
- K063583: Alcon Vision System (2008), 36 descendants of its own
- K082845: Infiniti Vision System with Ozil IP (2009), 22 descendants of its own
- K091777: Alcon Ultrachopper (2009), 20 descendants of its own
- K093305: Enhanced Ultra Vit Probe (2010), 18 descendants of its own
- K101285: Constellation Vision System (2010), 17 descendants of its own

## Indications for use
The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.

Source page: https://510kreport.com/device/K032598
Methodology: https://510kreport.com/methodology