# K070287: PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500

- Pathway: 510(k) (Traditional)
- Applicant: Photonic Optische Gerate GmbH & Cokg
- Decided: Feb 12, 2007 after 14 days
- Product code: EBA (Light, Surgical Headlight)
- Device class: 1
- Regulation: 21 CFR 872.4630
- 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K052979: 1125 XSB Xenon Fiber-Optic Light Source, Isolux, LLC (2005) Summary page 1.
- K991572: Isolux Surgical Headlight, Isolux America (1999) Summary page 1.
- K991208: Endoscopic Fiberoptic Cable, Isolux America (1999) Summary page 1.

## Indications for use
The AC-powered dental operating light, which can be attached via optical fibers to a surgical headlight, is a device intended to illuminate oral structures and operating areas.

Source page: https://510kreport.com/device/K070287
Methodology: https://510kreport.com/methodology