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 |