# K964005: Synergetics Synerlight Fiber Optic Lightsource

- Pathway: 510(k) (Traditional)
- Applicant: Synergetics, Inc.
- Decided: Jun 9, 1997 after 275 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
No predicates in its family tree.
40 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dutch Ophthalmic, USA Xenon Illumination System catalog number 1266-X: named in the summary without a submission number

## Most influential descendants
- K032598: Synergetics Synerlight Fiber Optic Lightsource (2003), 38 descendants of its own
- 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

## Indications for use
The Synergetics Fiber Optic Lightsource is indicated for use during anterior and posterior vitreoretinal surgery te illuminate-the eye.

Source page: https://510kreport.com/device/K964005
Methodology: https://510kreport.com/methodology