The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Lazersmile, Lazerwhite.
| Device ID | K000290 |
| 510k Number | K000290 |
| Device Name: | LAZERSMILE, LAZERWHITE |
| Classification | Toothbrush, Manual |
| Applicant | BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente, CA 92673 |
| Contact | Ioana M Rizoiu |
| Correspondent | Ioana M Rizoiu BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente, CA 92673 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-31 |
| Decision Date | 2000-04-14 |