# K061622: PS Series

- Pathway: 510(k) (Traditional)
- Applicant: Photonic Optische Gerate Gesmbh & Cokg
- Decided: Mar 5, 2007 after 266 days
- Product code: FFS (Image, Illumination, Fiberoptic, For Endoscope )
- 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 K983714 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983714: Solartec Source 270, Model # 90123, Cogent Light Technologies, Inc. (1998) Summary page 1.
- K001698: Micro Link Endoscopic Fiber Cable, Model B1-90159, Cogent Light Technologies, Inc. (2000) Summary page 1.
- K022384: Xenon Fiberoptic Light Source, Model 1300 XSBP, Isolux America (2002) Summary page 1.
- K991572: Isolux Surgical Headlight, Isolux America (1999) Summary page 1.
- (no number) 1125 XSB: named in the summary without a submission number

## Indications for use
The device is used to provide light for endoscopic devices. Those devices can be connected directly to the light source or by fiber bundles or single fibers. The device is intended for prescription use only.

Source page: https://510kreport.com/device/K061622
Methodology: https://510kreport.com/methodology