# K984124: Aesculap Xenon Light Source

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Feb 1, 1999 after 75 days
- Product code: FSS (Light, Surgical, Floor Standing)
- Device class: 2
- Regulation: 21 CFR 878.4580
- 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 K934559 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980044: Xenon 300MX, Perkinelmer Optoelectronics (1998) Summary page 2.
- K934559: Karl Storz Xenon Light Source Model 201320-20, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 2.
- K952696: Xenon Light Source Model 5121, Richard Wolf Medical Instruments Corp. (1995) Summary page 2.

## Cited in the summary but kept off the family tree
- K890716: Luxtec Aco Series 4000 Light Source, Luxtec Corp. (1989). Our OCR of the scanned summary read K890716, FDA’s number for Luxtec Aco Series 4000 Light Source (Luxtec Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lutex”. Kept off the family tree. Summary page 2.

## Indications for use
Aesculap's Xenon Light Source is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contain fiberoptic bundles. lilumination from this device is intended to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laparoscopy, gynecology, broncoscopy, urology, neuroendoscopy and vascular endoscopy.

Source page: https://510kreport.com/device/K984124
Methodology: https://510kreport.com/methodology