The following data is part of a premarket notification filed by Isolux Llc with the FDA for 1125 Xsb Xenon Fiber-optic Light Source.
| Device ID | K052979 |
| 510k Number | K052979 |
| Device Name: | 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | ISOLUX LLC 1045 COLLIER CENTER WAY SUITE #6 Naples, FL 34110 -8444 |
| Contact | Nilcolaos Andreoulakis |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-10-24 |
| Decision Date | 2005-10-31 |