The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for G-light.
| Device ID | K050059 |
| 510k Number | K050059 |
| Device Name: | G-LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry Joritz |
| Correspondent | Terry Joritz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-11 |
| Decision Date | 2005-02-03 |