WATERLASE, MILLENNIUM

Powered Laser Surgical Instrument

BIOLASE TECHNOLOGY, INC.

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

Pre-market Notification Details

Device IDK011041
510k NumberK011041
Device Name:WATERLASE, MILLENNIUM
ClassificationPowered Laser Surgical Instrument
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 CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-05
Decision Date2001-07-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.