LAZERSMILE, LAZERWHITE

Toothbrush, Manual

BIOLASE TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Lazersmile, Lazerwhite.

Pre-market Notification Details

Device IDK000290
510k NumberK000290
Device Name:LAZERSMILE, LAZERWHITE
ClassificationToothbrush, Manual
Applicant BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente,  CA  92673
ContactIoana M Rizoiu
CorrespondentIoana M Rizoiu
BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente,  CA  92673
Product CodeEFW  
CFR Regulation Number872.6855 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-31
Decision Date2000-04-14

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