The following data is part of a premarket notification filed by Isolux Llc with the FDA for Optilux Led Illuminator.
| Device ID | K163185 |
| 510k Number | K163185 |
| Device Name: | OptiLux LED Illuminator |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | ISOLUX LLC 1045 COLLIER CENTER WAY SUITE #6 Naples, FL 34110 |
| Contact | Nikolaos Andreoulakis |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2016-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852350007020 | K163185 | 000 |
| 01816835024246 | K163185 | 000 |
| 01816835024239 | K163185 | 000 |
| 01816835024222 | K163185 | 000 |
| 01816835024215 | K163185 | 000 |