The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Celalux 3.
| Device ID | K153018 |
| 510k Number | K153018 |
| Device Name: | CELALUX 3 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | VOCO GMBH Anto-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Contact | M Th. Plaumann |
| Correspondent | T. Gerkensmeier VOCO GMBH Anto-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-15 |
| Decision Date | 2016-06-23 |