The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Lasersmile.
| Device ID | K030539 |
| 510k Number | K030539 |
| Device Name: | LASERSMILE |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-20 |
| Decision Date | 2003-10-10 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LASERSMILE 77153295 not registered Dead/Abandoned |
BIOLASE Technology, Inc. 2007-04-10 |
![]() LASERSMILE 75181098 not registered Dead/Abandoned |
Passes, Harvey 1996-10-15 |