The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Genesis Diode Laser.
| Device ID | K062258 |
| 510k Number | K062258 |
| Device Name: | GENESIS DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE Amherst, NY 14228 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-04 |
| Decision Date | 2007-03-21 |
| Summary: | summary |