The following data is part of a premarket notification filed by Waldmann Lighting with the FDA for Halux Iris Examination And Surgical Lamp.
| Device ID | K053364 |
| 510k Number | K053364 |
| Device Name: | HALUX IRIS EXAMINATION AND SURGICAL LAMP |
| Classification | Lamp, Surgical |
| Applicant | WALDMANN LIGHTING PO BOX 7007 Deerfield, IL 6015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm WALDMANN LIGHTING PO BOX 7007 Deerfield, IL 6015 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-02 |
| Decision Date | 2006-02-23 |
| Summary: | summary |