# Isolux America

- Location (FDA's records): Naples, FL
- FDA decisions: 3 (1999–2002): 3 510(k) clearances
- Product codes: FST (1), HBI (1), HET (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Photonic Optische Gerate GmbH & Cokg: 3 (https://510kreport.com/company/photonic-optische-gerate-cokg)
- Photonic Optische Gerate Gesmbh & Cokg: 2 (https://510kreport.com/company/photonic-optische-gerate-gesmbh-cokg)
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)
- Schott North America: 1 (https://510kreport.com/company/schott-north-america)

## Its most-cited devices
- K991572: Isolux Surgical Headlight (1999), cited by 3
- K991208: Endoscopic Fiberoptic Cable (1999), cited by 2
- K022384: Xenon Fiberoptic Light Source, Model 1300 XSBP (2002), cited by 2

## Recent decisions
- K022384: Xenon Fiberoptic Light Source, Model 1300 XSBP (Oct 18, 2002)
- K991572: Isolux Surgical Headlight (Jul 8, 1999)
- K991208: Endoscopic Fiberoptic Cable (Jun 23, 1999)

Source page: https://510kreport.com/company/isolux-america