Waterlase IPLus

Powered Laser Surgical Instrument

Biolase, Inc.

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

Pre-market Notification Details

Device IDK210183
510k NumberK210183
Device Name:Waterlase IPLus
ClassificationPowered Laser Surgical Instrument
Applicant Biolase, Inc. 27042 Towne Centre Drive, Suite 270 Foothill Ranch,  CA  92610
ContactKaty Nennig
CorrespondentKaty Nennig
Biolase, Inc. 27042 Towne Centre Drive, Suite 270 Foothill Ranch,  CA  92610
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-25
Decision Date2022-04-21

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